Events

Alerte De Sécurité sur · CELL-DYN 3700, List Numbers: 02H31-01, (SL). Registration number: 10055310993 for Model SL. CELL-DYN 3500, List Numbers: 91340-01, (CS), 91350-01, (SL), Registration Number: 10055310618 for Model SL, Registration Number: 10055310575 for Model CS. CELL-DYN 3200, List Numbers: 04H59-01, (CS), 04H60-01, (SL), Registration Number: 10055310800 for Model SL, Registration Number: 10055310797 for Model CS. CELL-DYN 3000, List Numbers: 9123-01, (CS), 91325-01, (SL), Registration Number: 10055310124 for Model SL, Registration Number: 10055310123 for Model CS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Abbott Diagnostics Division.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    787
  • Date
    2004-07-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The failure of the CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYN 3000 Equipment in flagging a sample with a falsely high WBC count due to the presence of an interfering substance may cause the results of Patient's WBC are reported incorrectly and therefore result in a negative effect on patient safety. This does not affect user safety. Labeling is affected because the Operations Manual states that the WOC can be reported if there is no other suspect parameter signaling. In the customer complaint that initiated this action, the sample report did not present any suspicious parameter, but the WOC count was inaccurate and therefore could not be reported. To date, no damage has been associated with this occurrence in the CELL- DYN 3000, CELL-DYN 3500, CELL-DYN 3000 and CELL-DYN 3000. · Review all CELL-DYN 3000 Series Equipment Operation Manuals to determine if interference information (WBC count in the presence of NRBCs and missing ability to provide accurate WBC counts in the presence of NRBCs) require revision. · Update Operational Manuals (CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYN 3000) as needed to include NRBCs as a potential interference to WOC counting, and information on how to proceed interference.
  • Cause
    Discrepancy in the results of the total white blood cell (vbc) count in the sample of a thalassemia patient, when using the cell-dyn 3700 equipment. the result of cell-dyn 3700 for woc (optical white cell count) was significantly higher than the wbc count determined by the manual method. the source of interference for the woc could not be determined through the information received from the client, but it should be noted that the nrbcs (nucleated red blood cells) present in the sample were being included in the woc, making the count imprecise. the woc parameter is available on the cell-dyn 3700, cell-dyn 3500 and cell-dyn 3200 devices.
  • Action
    The WOC parameter is available on the CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYM 3000 equipments. Note that the WOC on the CELL-DYN 3000 is called the WBC (total white cell). The WOC in these equipments was designed to apply thresholds, which exclude NRBCs from the WBC analysis. This ability is reflected in product labeling, which currently states that the WOC will provide an accurate estimate of WBCs in patient samples containing NRBCs. While this is true for the vast majority of samples, an investigation by Abbott demonstrated that the WOC result in CELL-DYN 3700 was significantly greater than WBC as determined by haemocytometry in a patient with a high number of NRBC s (> 100 NRBC / 100 WBC s). We are therefore taking the opportunity to inform users that this phenomenon may occur, and also to review the Operations Manuals to reflect this information. ACTIONS REQUIRED WIC ALERTS. WOC or KWOC - If a reported WBC value displayed on the screen your analyzer has one of the WIC, WOC or KWOC descriptor alerts next to it, refer to the list of potentially interfering substances in the Operation Manual for your CELL-DYN 3000 Series Equipment, and follow your lab procedures to confirm the result. ALERTS for NRBC - If a reported WBC value displayed on your analyzer screen has NRBC signaling next to it, review the smear to check for NRBCs and follow your laboratory's review criteria. If NRBCs are present, these should be quantified according to your laboratory procedures. If WBC correction is required, proceed as follows: · On the CELL-DYN 3500 and CELL-DYN 3700 Instruments, correct the WIC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected WIC (or WOG value confirmed) can be reported. · On the CELL-DYN 3200 instrument, analyze the patient sample in the NOC mode, correct the NOC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected NOC (or confirmed WOC value) can be reported. · On the CELL-DYN 3000 Instrument, check a smear for the presence of NRBCs and check the WBC count by an alternate method. If you have sent your CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 or CELL-DYM 3000 to another laboratory, please provide a copy of this letter to you.

Device

· CELL-DYN 3700, List Numbers: 02H31-01, (SL). Registration number: 10055310993 for Model SL. CEL...

Manufacturer

Abbott Diagnostics Division
  • Source
    ANVSANVISA