BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1961416 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00251
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TESTED 23 MG/DL ON THE AVIVA SYSTEM; LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THIS RESULT. PARAMEDICS WERE CALLED, AND CUSTOMER TESTED 26 MG/DL ON PROFESSIONAL DEVICE. CUSTOMER THEN RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM: 486 MG/DL, 160 MG/DL, AND 29 MG/DL. ALL REPORTED RESULTS WERE OBTAINED WITHIN 10 MINUTES. CUSTOMER WAS TREATED WITH A GLUCAGON INJECTION AND WAS ABLE TO DRINK GRAPE JUICE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR N-ACETYL CYSTEINE| DIOVAN| HYDROCHLOROTHIAZIDE| LANTUS| HUMALOG| ASPIRIN| ASSORTED VITAMINS| NORTRIPTYLINE| ALPHA-LIPOIC ACID