BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3935402 · Received July 15, 2014

    Report

    Report Number
    1823260-2014-05240
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 20807942, EXPIRATION DATE 11/30/2014). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A RESULT OF 14.0 MMOL/L ON COMPACT PLUS SYSTEM 1, AND A RESULT OF 2.1 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. HE WAS TREATED WITH WATER WITH SUGAR AND AN AMBULANCE WAS CALLED. THE CUSTOMER DID NOT RECEIVE PROFESSIONAL MEDICAL TREATMENT, AND THE AMBULANCE WAITED WITH THE CUSTOMER UNTIL HIS RESULT WAS 5.0MMOL/L. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414108 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20807942

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR