BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2023739 · Received March 18, 2011

    Report

    Report Number
    1823260-2011-01493
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 46 MG/DL AND 135 MG/DL. CUSTOMER REPORTED THAT SHE WAS FEELING HYPOGLYCEMIC SYMPTOMS OF SHAKINESS AND OBTAINED THE READING OF 46 MG/DL. CUSTOMER CONSUMED A TANGERINE AND THEN OBTAINED THE READING OF 135 MG/DL. 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 303179

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR LISINOPRIL| GLIPIZIDE| LOVASTATIN| BYETTA| METFORMIN