Events

Alerte De Sécurité sur CoaguChek XS Pro

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par 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
  • Date
    2013-02-19
  • Date de publication de l'événement
    2013-02-19
  • 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_20130219b.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: roche coaguchek xs pro medical device manufacturer, roche diagnostics gmbh issued a medical device safety alert concerning an issue with erroneous decoding of ean 13 barcodes used on coaguchek xs pro. roche explained that for ean 13, iso/iec 15420 is applicable. there are 10 sizes (sc0…sc9) are specified in iso/iec 15420, with a“standard size’’ sc2 = 100%. the smallest specified symbol size (class sc0, 81.8%) is 30.50 x 21.48 mm with a module width of 0.27mm. the barcodes on the wrist bands of a customer in europe were only at approximately 49% of the sc2 standard size. on the other hand, the quality of the barcodes was found to have some deficiencies as regards correctness of guard bar and other width patterns. therefore, some ean 13-coded patient ids on wrist bands were intermittently decoded erroneously. roche will further assess further possibilities to reduce the probability of occurrence for this issue by modification to the barcode security level scanner settings. users are suggested to: ensure size and quality of barcodes used follow the applicable standards for all barcode types. avoid using ean 13 barcode types for patient and operator identification as far as possible. according to the local supplier, roche diagnostics (hong kong) limited, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

CoaguChek XS Pro
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche CoaguChek XS Pro
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH