BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 4241064 · Received November 10, 2014

    Report

    Report Number
    1823260-2014-08739
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 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
    AR
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FEELING COLD, SWEATY, AND BECAME UNCONSCIOUS WITH A RESULT OF 438 MG/DL OBTAINED ON THE PERFORMA SYSTEM. THE CUSTOMER WAS TAKEN BY AMBULANCE TO THE HOSPITAL, WHERE HE TESTED 15 MG/DL ON A PROFESSIONAL DEVICE. THE TIMEFRAME BETWEEN THE RESULTS IS UNKNOWN. TYPE OF MEDICAL TREATMENT WAS NOT PROVIDED. THE CUSTOMER REMAINS IN THE HOSPITAL. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722723 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473273

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male CARDIOASPIRINA TWICE DAILY| LEVEMIR FLEXTOUCH| LEVOCAR DAILY| LOSARTAN TWICE DAILY| NOVORAPID FLEXPEN TWICE DAILY| LEVOCAR DAILY| LEVEMIR FLEXTOUCH| NOVORAPID FLEXPEN TWICE DAILY| LOSARTAN TWICE DAILY| CARDIOASPIRINA TWICE DAILY