BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1770631 · Received July 27, 2010

    Report

    Report Number
    2939301-2010-05924
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Report Date
    July 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING AN ERROR 1 MESSAGE ON HER ONE TOUCH PING METER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE FIRST BEGAN ON (B)(6) IN BETWEEN 9-10:00PM. THE PATIENT SELF-TREATED WITH 6-7 UNITS OF HUMALOG. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE AND WAS NOT TESTED ON ANOTHER DEVICE. THE ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED. AT THIS TIME, THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR RECEIVING ANY MEDICAL ATTENTION. THE COMPLAINT IS BEING REPORTED SINCE THE ERROR 1 ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2978137

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR