BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1882053 · Received October 25, 2010

    Report

    Report Number
    1823260-2010-06353
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED VOICEMATE BLOOD GLUCOSE RESULTS OF 400 MG/DL, 364 MG/DL 2 MINUTES LATER, AND 184 MG/DL WITHIN 4 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 ROCHE DIAGNOSTICS NA 551258

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR LISINOPRIL 5MG| 1 MULTI VITAMIN| NOVOLIN N| ASPIRIN 81 MG| OMEPRAZOLE 20 MG| FUROSEMIDE 40MG| NOVOLIN R