BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1883621 · Received October 26, 2010

    Report

    Report Number
    2939301-2010-09479
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K082590.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 BLACK MARKS ON THEIR ONE TOUCH PING METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE WITH THE METER BEGAN ON (B)(6), 2010 AT AROUND 12:30PM. THE PATIENT TOOK THEIR USUAL DOSAGE OF MEDICATION AT AROUND 1:00PM, THE PATIENT DEVELOPED SYMPTOMS OF FREQUENT URINATION AND STOMACH ISSUES AND DID NOT SELF-TREAT OR SEEK ANY FURTHER MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE OR SYMPTOMS. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE BLACK MARKS ON THE METER THEY WERE UNABLE TO TEST AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3047256

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening