BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1236203 · Received October 24, 2008

    Report

    Report Number
    1823260-2008-07873
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 24, 2008
    Manufacturer
    RROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 146 MG/DL, 414 MG/DL AND 185 MG/DL. WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ACTIVE S SYSTEM. REPORTER STATED SHE TOOK INSULIN BASED ON THE 146 MG/DL RESULT. REPORTER STATED THAT A DIFFERENT TIME ANOTHER COMPARATIVE TEST OF 400-499 MG/DL WAS PERFORMED BACK TO BACK WITH A RESULT OF 140-159 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR RROCHE DIAGNOSTICS 22981331

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR METOPROLOL - 1 YEAR - 25 MG TWICE DAILY| LEVEMIR - 1 YEAR - 65 UNITS ONCE DAILY| NOVOLOG - 1 YEAR - SLIDING SCALE| VITAMIN B12 - 1 YEAR - 1000 MCG ONCE DAILY| LIPITOR - 1 YEAR - 20 MG ONCE DAILY| "L-THYROXINE" - 1 YEAR - 50 MCG ONCE DAILY| IRON - 1 YEAR - 65 MG ONCE DAILY