BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1213863 · Received October 28, 2008

    Report

    Report Number
    1823260-2008-07966
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    August 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 346 MG/DL BACK TO BACK WITH A RESULT OF 46 MG/DL ON THE AVIVA SYSTEM, WHEN TESTING WAS PERFORMED WITHIN 10 MINS. REPORTER INDICATED THAT HE TOOK 17 UNITS OF HUMALOG BASED ON THE 346 MG/DL READING, AND FORGOT TO EAT HIS SNACK AS HE NORMALLY DOES. REPORTER STATED HE PASSED OUT AFTER THE 46 MG/DL RESULT WAS OBTAINED. REPORTER STATED THE EMTS WERE CALLED, THEY OBTAINED A RESULT OF 43 MG/DL, AND THEY GAVE AN IV OF SALINE AND GLUCOSE GEL. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 301107

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention HUMALOG- 3 YEARS| LANTUS- 2 YEARS