BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1882680 · Received October 26, 2010

    Report

    Report Number
    1823260-2010-06362
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 586 MG/DL, 95 MG/DL, HI (GREATER THEN 600 MG/DL), AND 69 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER STATES SHE WAS ON AN AIRPLANE FLYING AT AN ALTITUDE OF 27,000 FEET WHEN THESE RESULTS WERE OBTAINED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 302129

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR UNSPECIFIED INSULIN| AVAPRO| VITAMIN D| CALCIUM| UNSPECIFIED INSULIN PUMP| BABY ASPIRIN| CRESTOR