BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 732568 · Received July 6, 2006

    Report

    Report Number
    1823260-2006-03394
    Event Type
    Injury
    Date Received
    July 6, 2006
    Date of Event
    January 1, 2004
    Report Date
    June 7, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DESCRIBED IN A JOURNAL ARTICLE, ENTITLED "INTRAGAM CAN INTERFERE WITH BLOOD GLUCOSE MONITORING," PUBLISHED IN THE MEDICAL JOURNAL OF AUSTRALIA (MJA 2004; 180(5): 251-252). THIS ARTICLE WAS FORWARDED TO MANUFACTURER BY THE FOOD AND DRUG ADMINISTRATION ON 06/07/2006.

    Description of Event or Problem · 1

    WHILE RECEIVING AN INTRAVENOUS INFUSION OF A HUMAN NORMAL IMMUNOGLOBULIN (CONTAINING 10% MALTOSE - A LABELED INTERFERENT FOR THE TEST STRIPS), A PATIENT'S CAPILLARY BLOOD GLUCOSE WAS MEASURED, USING THE SUSPECT DEVICE, WITH A RESULT OF 9.3 MMOL/L. AT THE SAME TIME, PATIENT'S PLASMA BLOOD GLUCOSE MEASURED 2.3 MMOL/L ON A HOSPITAL DEVICE (TYPE NOT PROVIDED). AN ADDITIONAL COMPARISON, WHILE RECEIVING THE IVIG INFUSION WAS REPORTEDLY PERFORMED ON THE SAME PATIENT: CAPILLARY VALUE ON SUSPECT DEVICE WAS 24.4 MMOL/L, WHILE THE PLASMA VALUE MEASURED 10.4 MMOL/L. BASED ON THE FALSELY ELEVATED VALUES OBTAINED ON THE SUSPECT DEVICE, PATIENT WAS REPORTEDLY TREATED WITH INSULIN (AMOUNT AND TYPE NOT PROVIDED). PATIENT REPORTEDLY DEVELOPED HYPOGLYCEMIA DUE TO INSULIN ADMINISTRATION. NO DETAILS OF PATIENT'S SUBSEQUENT TREATMENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PREDNISONE| ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITOR| INTRAGAM P| INSULIN