BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1902650 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06836
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 23 MG/DL AND 76 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER ALLEGED OBTAINING THE RESULTS OF 150 OR 160 MG/DL AND 91 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE SAME COMPACT PLUS SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 207248

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR WARFARIN (VARIABLE ON INR RESULTS)| INR HOME TESTING MACHINE| PROSCAR (DAILY)| LISINOPRIL (DAILY)| CELEXA (DAILY)| SULINDAC (TWICE DAILY)| CLARITIN (DAILY)| HYDROCHLOROTHIAZIDE (DAILY)| ZOCOR (DAILY)