BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3954982 · Received July 24, 2014

    Report

    Report Number
    1823260-2014-05474
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 29, 2025
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE PERFORMA SYSTEM (LOT NUMBER 471615, EXPIRATION DATE 12/31/2014). (B)(4). DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A RESULT OF 102 MG/DL ON THE MOBILE SYSTEM, AND A RESULT OF 56 MG/DL ON THE PERFORMA SYSTEM. THE CUSTOMER FELT HYPOGLYCEMIC WITH THESE RESULTS. ON A DIFFERENT OCCASION THE CUSTOMER RECEIVED A RESULT OF 92 MG/DL ON THE MOBILE SYSTEM, AND A RESULT OF 42 MG/DL ON THE PERFORMA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE TEST STRIPS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433940 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471615

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female