BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELEMENT CONTROL SOLUTION

    MDR report key: 2192705 · Received June 24, 2011

    Report

    Report Number
    3004146366-2011-00001
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INFOPIA
    Product Code
    NBW
    PMA / PMN Number
    K072369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFOPIA (B)(4) REPLACED THE INCORRECT LABELS WITH THE CORRECT LABEL. AND INFOPIA (B)(4) (DISTRIBUTOR) AN (B)(4) (SUPPLIER) INSPECT THEIR CUSTOMER WHO RECEIVED THE CONTROL SOLUTION MISLABELED LOT NUMBER AND MAIL TO THEM.

    Description of Event or Problem · 1

    THE CONTROL SOLUTION IN LOT NUMBER (CN9LA06) IS NORMAL CONTROL SOLUTION BUT IS MARKED LOW ON LABEL. NO ADVERSE EVENT REPORTED. INFOPIA (B)(4) (MFR) REPLACED THE INCORRECT LABELS WITH THE CORRECT LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEMENT CONTROL SOLUTION BLOOD GLUCOSE MONITORING CONTROL SOLUTION NBW INFOPIA CN9LA06

    Patients

    Seq Age Sex Outcome Treatment
    1 ELEMENT TEST METER| ELEMENT TEST STRIP