BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA TEST STRIPS

    MDR report key: 2223293 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04562
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 470128, EXPIRATION DATE 04/30/2012). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON PERFORMA SYSTEM 1/PERFORMA SYSTEM 2 WITHIN 10 MINUTES: 15MG/DL AND 64 MG/DL; 35 MG/DL AND 88 MG/DL. THE COMPARISONS WERE PERFORMED APPROXIMATELY 30 MINUTES APART. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470128

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR