BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1190332 · Received October 6, 2008

    Report

    Report Number
    1823260-2008-07382
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYS 2. REFERENCE MEDWATCH FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYS 1.

    Description of Event or Problem · 1

    THE CALLER STATES THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE HE WAS INCOHERENT, "OUT OF IT" AND DID NOT KNOW WHAT WAS GOING ON. THE CUSTOMER'S BLOOD GLUCOSE WAS 90 MG/DL ON THE ACCU-CHEK AVIVA SYS. THE CALLER ATTEMPTED TO TREAT THE CUSTOMER WITH ORANGE JUICE. THE CALLER WAS UNSUCCESSFUL. WITHIN 10 MINS, THE CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL ON THE PROFESSIONAL METER. THE EMERGENCY MEDICAL TECHNICIAN'S TREATED THE CUSTOMER WITH GLUCOSE. THE RESULTS OF THE TREATMENT WERE UNDISCLOSED. THE CUSTOMER HAS TWO ACCU-CHEK AVIVA SYS. THE CALLER DID NOT KNOW WHICH SYS PRODUCED THE 90 MG/DL RESULT. NEW SYS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 301241

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention GLIPIZIDE| LANTUS