BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2252671 · Received September 19, 2011

    Report

    Report Number
    1823260-2011-04935
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 29, 2011
    Report Date
    November 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 365 MG/DL AND 65 MG/DL. CUSTOMER HAD BLURRY VISION AND FELT LIKE HIS BLOOD SUGAR WAS LOW, SO HE TESTED AND OBTAINED THE READING OF 365 MG/DL. HE RETESTED AND OBTAINED THE READING OF 65 MG/DL. HE DRANK SOME ORANGE JUICE IN RESPONSE TO THE READING OF 65 MG/DL AND FELT BETTER IN A FEW MINUTES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 303282

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR HUMALOG INSULIN| LISINOPRIL 1X DAILY