BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1170759 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06900
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 418 MG/DL BACK TO BACK WITH A RESULT OF 158 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 301324

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR METFORMIN/GLYBURIDE -MONTHS 5MG/500MG 3TIMES DAILY| ONE A DAY VITAMIN - LESS THAN 1 YR| "NORVAS" - MONTHS| LANTUS - 9 MONTHS 5-6MG DAILY| "COLR-COM POTASSIUM" - MONTHS 10MG DAILY| METOPROLOL- MONTHS 50MG DAILY| FISH OIL -MONTHS 100MG DAILY| OMEPRAZOLE - MONTHS 20MG DAILY| GABAPENTIN -MONTHS 600MG TWICE DAILY| LISINOPRIL HCTZ - MONTHS 20-25MG DAILY| VITAMIN C - MONTHS 500MG DAILY| VITAMIN B12 AND B6 - MONTHS| LOVASTATIN - MONTHS