BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1213302 · Received October 27, 2008

    Report

    Report Number
    1823260-2008-07938
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE CUSTOMER OBTAINED THE BLOOD GLUCOSE RESULT OF 237MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE CUSTOMER WAS GIVEN 10 UNITS OF HUMALOG 75/25 (CUSTOMER GIVEN INSULIN AT LATER TIME THAN NORMALLY PRESCRIBED). SIX MINUTES LATER, THE CUSTOMER OBTAINED A BLOOD GLUCOSE RESULT OF 124MD/DL (SAME SYSTEM). THE CUSTOMER WAS SHAKING, SWEATING AND MUMBLING. THE CUSTOMER WAS GIVEN SODA WHICH SHE CONSUMED ON HER OWN. THE CUSTOMER'S SYMPTOMS DID NOT IMPROVE. THE PARAMEDICS WERE CALLED. THE CUSTOMER'S BLOOD GLUCOSE WAS 40MG/DL ON THE PROFESSIONAL METER (22-37 MINUTES AFTER THE 124MG/DL RESULT). THE PARAMEDICS INITIALLY ATTEMPTED TO TREAT THE CUSTOMER WITH GLUCOSE GEL. THE CUSTOMER EXPERIENCED DIFFICULTY WITH SWALLOWING THE GEL. THE PARAMEDICS TREATED THE CUSTOMER WITH INTRAVENOUS THERAPY (UNKNOWN CONTENTS). THE CUSTOMER FELT BETTER 15 MINUTES FOLLOWING TREATMENT. THE CUSTOMER NORMAL BLOOD GLUCOSE RANGE IS 70-180 MG/DL. NEW SYSTEM 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 301351

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention HUMALOG 75/25