BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220059 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08066
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 491 MG/DL AND 223 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. IN A SEPARATE INCIDENT, THE CUSTOMER REPORTED BACK-TO-BACK BLOOD GLUCOSE RESULTS OF HI (GREATER THAN 600 MG/DL) AND 169 MG/DL ON THE SAME SYSTEM. CUSTOMER REPORTED SELF-TREATING WITH INSULIN IN BOTH CASES. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS- LFR LFR ROCHE DIAGNOSTICS 550773

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR FLOMAX - 4 MOS- 0.4 MG DAILY| PLAVIX - 4 MOS- 75 MG DAILY| METOLAZONE - 4 MOS- 25 MG TWICE DAILY| UROSEMIDE - 4 MOS- 20 MG DAILY| RISPERIDONE - 4 MOS- 0.5MG TWICE DAILY| ASPIRIN - 4 MOS- 325 MG DAILY| BACLOFEN - 1 MOS- 10MG DAILY| LEVOTHYROXINE - 4 MOS- 0.05 MG DAILY| AMLODIPINE - 4 MOS 10 MG DAILY| ATENOL - 4 MOS 25 MG DAILY