BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2210423 · Received August 12, 2011

    Report

    Report Number
    1823260-2011-04332
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER STATED THAT SHE BOTTOMED OUT WHILE SLEEPING AND WAS UNCONSCIOUS WHEN SHE WAS TESTED WITH A RESULT OF 81 MG/DL ON THE AVIVA SYSTEM. THE EMTS TESTED HER WITH A RESULT OF 20 MG/DL ON THEIR SYSTEM AND TREATED THE CUSTOMER WITH D-50 INTRAVENOUSLY. THE REPORTER DID NOT KNOW THE TIMEFRAME BETWEEN THE RESULTS. REPORTER STATED THAT SHE ATE AFTER THAT. NO OTHER 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303139

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR LANTUS| NOVOLOG| PRENATAL VITAMINS| LOVENOX| ASPIRIN