BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1964419 · Received January 19, 2011

    Report

    Report Number
    2939301-2011-00620
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Report Date
    January 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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.THE 510(K)# IS K082590.

    Description of Event or Problem · 1

    COMPLAINT IS BEING REPORTED BECAUSE THE METER ALLEGEDLY DISPLAYS AN UNKNOWN ERROR MESSAGE. THE REPORTER WAS UNABLE TO RECALL THE SPECIFIC ERROR MESSAGE DISPLAYED. 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 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3009817

    Patients

    Seq Age Sex Outcome Treatment
    1