BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2013574 · Received March 10, 2011

    Report

    Report Number
    2939301-2011-02047
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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) 2011 ALLEGING INACCURATE ERRATIC READINGS ON HER ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT SHE HAD TESTED ON HER METER AND OBTAINED A 651 MG/DL AND 660 MG/DL ON HER LFS METER. READINGS WERE LESS THAN 20 MINUTES FROM ONE ANOTHER. DUE TO THE ALLEGED HIGH READINGS, THE PATIENT INCREASED HER DOSAGE OF ORAL MEDICATION. AT AN UNSPECIFIED TIME LATER, SHE FELT SHAKY AND HOT. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, SHE TOOK AN INCREASE DOSAGE OF INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening