BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1770595 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09327
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 7, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE OF 244 MG/DL BACK TO BACK WITH A RESULT OF EITHER 72 OR 77 MG/DL WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART ON THE AVIVA SYSTEM. REPORTER INDICATED HE SELF-TREATED WITH FOOD FOR THE HYPOGLYCEMIC SYMPTOMS HE WAS EXPERIENCING DURING THE TIME OF TESTING. 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 300470

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR OMEPRAZOLE - 6 MONTHS, 20 MG/ONCE DAILY| FOLIC ACID - 6 MONTHS, 1 MG/ONCE DAILY| NOVOLOG - SLIDING SCALE| LISINOPRIL - 6 MONTHS, 10 MG/1/2 TAB DAILY| PAIN MEDICATION - 6 MONTHS, 600 MG/3 TIMES DAILY| GABAPENTIN - 6 MONTHS, 300 MG/THREE TIMES DAILY| METHOTREXATE - 6 MONTHS, 2.5 MG/6 TABS ON SUNDAY| HYDROCODONE APAP - 6 MONTHS, 500 MG/EVERY 6 HRS| AS NEEDED| HYDROXYCHLOROQUINE SULFATE - 6 MONTHS,| 200 MG/TWICE DAILY| TRAZODONE HCL - 4 YEARS, 100 MG/TWICE DAILY| HTL FLUOXETINE HCL 6 MONTHS, 20 MG/4 TIMES DAILY