BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-CHEK SENSOR III MG/DL

    MDR report key: 760771 · Received September 12, 2006

    Report

    Report Number
    1823260-2006-04988
    Event Type
    Other
    Date Received
    September 12, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 31, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT EXPERIENCED SEVERE HYPOGLYCEMIA, ON AT LEAST 2 OCCASIONS, COINCIDENT TO EXTRANEAL THERAPY (A LABELED INTERFERENT FOR THE TEST STRIPS). PT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED, USING THE SUSPECT DEVICE, WITH RESULTS OF APPROX. 140 MG/DL. AT THE TIME THE RESULTS WERE OBTAINED, PT WAS EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. THE NURSING STAFF QUICKLY SUSPECTED THAT THE ELEVATED RESULTS WERE DUE TO AN INTERFERENCE WITH GDH-PQQ STRIPS AND EXTRANEAL AND REPORTEDLY SWITCHED TO GLUCOSE-SPECIFIC TEST STRIPS. ADDITIONAL DETAILS OF PT'S DIAGNOSIS AND TREATMENT WERE NOT PROVIDED. NO CONSEQUENCES TO PT WERE REPORTED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SENSOR III MG/DL BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other EXTRANEAL| DIANEAL| NUTRINEAL| ACCU-CHEK TEST STRIPS (TYPE NOT PROVIDED)