Events

Alerte De Sécurité sur DxH 500 Hematology Analyser

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Beckman Coulter.

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
  • Date
    2017-05-29
  • Date de publication de l'événement
    2017-05-29
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170529.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: beckman coulter dxh 500 hematology analyser medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its dxh 500 hematology analyser [reference: b40601; software versions 1.0.2]. as a result of internal investigations, the manufacturer has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use stating that “the run sample is inaccessible”. results generated in this scenario may be erroneous. additionally: the message on the results screen/printout reads “instrument temperature” instead of “instrument temperature out of range”. the results are transmitted to the laboratory information system (lis) without the accompanying “instrument temperature out of range” message. using the auto-transmit option could lead to the release of erroneous results to the lis. if the instrument is operating out of the temperature range and the warnings on the screen are ignored and the results are used, then: these cbc, wbc-diff or cbc/wbc-diff results may be erroneous. if these erroneous results are released to the physician, this could result in inappropriate patient management. the manufacturer advises affected users to take the following actions:- when the message “instrument temperature out of range” or “instrument temperature” is displayed on the system or printouts, do not report the patient results. ensure the laboratory ambient temperature is within specifications (18°c -32°c) when processing samples. disable the auto-transmit option if there is a potential for the operational temperature to be exceeded. consult with the medical director to determine if a retrospective review of results is warranted. this issue will be corrected in a future software release. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 may 2017.

Device

DxH 500 Hematology Analyser
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter DxH 500 Hematology Analyser
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter