BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2020702 · Received March 16, 2011

    Report

    Report Number
    1823260-2011-01433
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 6, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 68 MG/DL AND 110 MG/DL, 96 MG/DL AND 180 MG/DL THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 ROCHE DIAGNOSTICS NA 303015

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR ASPIRIN| TRAMADOL 3 TIMES DAILY| ATENOLOL ONCE DAILY| LOTREL ONCE DAILY| GLYBURIDE ONCE DAILY| LIPITOR| ZETIA| FLOMAX| FISH OIL TWICE DAILY| PANTOPRAZOLE ONCE DAILY| ALLOPURINOL ONCE DAILY