BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 1860822 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05993
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CUSTOMER WAS UNSURE WHICH LOT PRODUCED THE DISCREPANT RESULT OBTAINED ON THE MOBILE SYSTEM. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN MOBILE SYSTEM 2 (LOT NUMBER 27706131, EXPIRATION DATE 10/31/2011). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 3.4 MMOL/L ON EITHER COMPACT PLUS SYSTEM 1 OR ON COMPACT PLUS SYSTEM 2 AND 14.0 MMOL/L ON EITHER MOBILE SYSTEM 1 OR ON MOBILE SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 27706131

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR "NORAPID"| LANTUS