BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING ENHANCED METER

    MDR report key: 1992359 · Received February 15, 2011

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    Report

    Report Number
    2939301-2011-01395
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    February 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. PRODUCT CODE FOR THIS DEVICE IS NBW.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE BATTERY LIFE IS SHORTER THAN EXPECTED FOR THE METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR