BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2821576 · Received November 6, 2012

    Report

    Report Number
    1823260-2012-05636
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 7, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 586 MG/DL, 292 MG/DL, 200 MG/DL, 230 MG/DL, 178 MG/DL, AND 181 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490921

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR PROMETHAZINE| LOSARTAN| PIOGLITAZONE| IPRATROPIUM/BROMIDE INHALER| NOVOLIN INSULIN| BLOOD PRESSURE METER| BUDESONIDE INHALER160/FORMOTER| TERAZOSIN| SIMVASTATIN| METOPROLOL SUCCINATE| BUPROPION| OMEPRAZOLE| GLIPIZIDE| CYCLOBENZAPRINE| HYDROCODONE| GABAPENTIN| HYDROCHLOROTHIAZIDE| NIACIN| ALBUTEROL INHALER| LANTUS INSULIN