Events

Alerte De Sécurité sur Commercial name: Cobas c 111 analyzer (with and without ISE) Technical name: Biochemical analyzer ANVISA registration number: 10287410612 Hazard class: I

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 Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

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
    2155
  • Date
    2016-10-14
  • 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
    1) Actions when measuring time error 7002: 108000572 occur (Annex 1) I) Error Identification: If the LED lights up red / the alarm button on the right side of the instrument turns red (Fig. / 1.1), the operator must act as described in the relevant operator's manual (section "React to messages"). ) Actions to be taken by the Client / User: Whenever the error reported as "7002: 108.000.572 a software error occurred" (Fig 2 / 2.1) is listed in the message list, the following procedure must be applied: 1 (See Fig 2 / 2.1) 2. Analyze the samples being processed from the exact time the error occurred (Fig 3 and 4 / 3.1 and 4.1) All samples processed from this date and time need to be re-run 3. Restart the system 4. Re-measure all the respective sample tests in order to ensure the absence of potentially erroneous results. 2) Fill out the form contained at the end of the notification and send it to e-mail brasil.tecnovigilancia@roche.com For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Recently the manufacturer roche diagnostics gmbh was aware of a software problem that can lead, in very rare cases, to erroneous results in the cobas c 111 analyzer (without ise unit). the cobas c 111 analyzers with the ise unit are not affected while the ise is in the ready state. so far, no field problem has been reported in which the identified software error has actually produced erroneous results. if the software error "measurement time error 7002: 108000572" occurs in the cobas c 111 analyzer, we stress the importance of following the instructions reported in the notification in order to avoid potential erroneous results. by december 2016, a final solution will be released through a patched software version.
  • Action
    Field Action Code SBN-CPS-2016-015 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Commercial name: Cobas c 111 analyzer (with and without ISE) Technical name: Biochemical analyzer...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH