BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA

    MDR report key: 2012353 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01299
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). AFTER THE METER HAD LEFT CONTROL OF ROCHE, THE ACTUAL METER LABEL WAS REMOVED AND REPLACED WITH THE LABEL FROM A DIFFERENT METER.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED THIS ACCU-CHEK PERFORMA MG/DL METER IS DISPLAYING RESULTS IN MMOL/L. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK PERFORMA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR