BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2022729 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01487
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 RESULTS OF 180 MG/DL AND 67 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER SELF TREATED WITH ORANGE JUICE. CUSTOMER RE-TESTED 9 MINUTES LATER AND RECEIVED RESULT OF 144 MG/DL. 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 303005

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR NOVOLOG| LANTUS| SYMLIN PEN