BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1595699 · Received February 8, 2010

    Report

    Report Number
    1823260-2010-00879
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 15, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT COMPACT TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE "2007-07". THE MANUFACTURER'S RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 07/31/2006. NO ACTIONS OR TREATMENT WERE REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT COMPACT TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE "2007-07". THE MANUFACTURER'S RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 07/31/2006. NO ACTIONS OR TREATMENT WERE REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    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 20634841

    Patients

    Seq Age Sex Outcome Treatment
    1