BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1760956 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06184
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 525 MG/DL BACK TO BACK WITH A RESULT OF 126 MG/DL WHEN TESTING WAS PERFORMED 1 MINUTE APART ON THE AVIVA SYSTEM. REPORTER ALLEGED EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING AND A RELATIVE GAVE HIM FOOD AND MILK AS A RESULT. NO OTHER ACTIONS WERE 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 300419

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR DEMODEX - 20MG TWICE DAILY| ALTACE - 5MG ONCE DAILY| HUMALOG 21 YRS - 100 UNITS TWICE DAILY| HUMULIN 21 YRS - 100 UNITS TWICE DAILY| LEXAPRO - 20 MG 1 DAY| TOPROL - 25MG ONCE DAILY| LANTUS 21 YRS -100 UNITS TWICE DAILY| DIGITEK - 0.125MG ONCE DAILY| DITROPAN - 10MG ONCE DAILY| PLAVIX - 75 MG ONCE DAILY| ZETIA -10MG ONCE DAILY