BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1771805 · Received July 28, 2010

    Report

    Report Number
    2939301-2010-05975
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRA 2 METER. THE PATIENT FIRST NOTICED THE HIGH READINGS ON (B)(6) 2010. THE PATIENT HAD OBTAINED THE FOLLOWING READINGS AT UNSPECIFIED TIMES ON (B)(6) 2010: 328 MG/DL AND A 342 MG/DL . THE PATIENT WAS COMPARING METER READINGS TO FEELINGS/NORMAL RESULTS. AT AN UNSPECIFIED TIME LATER, THE PATIENT FELT SWEATY, HOT AND EXPERIENCED BLURRED VISION. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ELEVATED READING , AT AN UNSPECIFIED TIME LATER, THEY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2904888

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening