BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1060822 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04741
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 73 MG/DL, 53 MG/DL, AND 43 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER WENT TO THE HOSPITAL, AND BLOOD GLUCOSE RESULT ON HOSPITAL METER WAS 153 MG/DL (TIMEFRAME BETWEEN RESULTS UNK); NO TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 301152

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR VALIUM 10 MG 2/DAY 5 MONTHS| HUMULIN NPH SLIDING SCALE 8 YEARS| NOVOLOG SLIDING SCALE 8 YEARS| ZOLOFT 100 MG 2/DAY 15 YEARS| PROTONIX 40 MG 2/DAY - 10 YEARS| NEURONTIN 200 MG 1/DAY- 1 YEAR| REGLAN 5MG 4/DAY 1 YEAR| PHENERGAN AS NEEDED| CARDARESS 40 MG 1/DAY - 8 MONTHS| "GLUCODANBE" 500 MG 2/DAY 8 YEARS| SYNTHROID 0.325 MG 1/DAY 7-8 YEARS