BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2170763 · Received July 21, 2011

    Report

    Report Number
    1823260-2011-03887
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 19, 2011
    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 2 (LOT NUMBER 20728645, EXPIRATION DATE 06/30/2012). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 9.7 MMOL/L ON COMPACT PLUS SYSTEM 1 AND 2.7 MMOL/L ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. 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
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20728645

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR SYNTHROID ONCE A DAY| MEDTRONIC INSULIN PUMP| HUMALOG| MOTILIUM TWICE A DAY