BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1920226 · Received December 10, 2010

    Report

    Report Number
    2939301-2010-10661
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K051195. 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 (B)(4) ON (B)(6) 2010 ALLEGING THAT HIS ONE TOUCH ULTRA METER POWERS OFF DURING USE. THE PATIENT HAS HAD THE METER FOR APPROXIMATELY 10 MONTHS AND TESTS 4X A DAY. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH METER HAPPENS RIGHT AFTER THE CODE NUMBER APPEARS ON THE METER. THE ISSUE BEGAN ON (B)(6) 2010. SHORTLY AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS WHERE HE FELT SLEEPY, SWEATING, URINATION, "PINS AND LOSS OF FEELING ON THE ARMS" AND THE PATIENT EVENTUALLY FAINTED. THE PATIENT WAS TAKEN TO THE HOSPITAL BY HIS WIFE AND WAS TREATED WITH INSULIN AND ORAL MEDICATION. PATIENT REGAINED CONSCIOUSNESS 4-5 HOURS LATER. WHEN THE PATIENT REGAINED CONSCIOUSNESS HE WAS TOLD HIS BLOOD GLUCOSE WAS 450 MG/DL AFTER HE HAD REGAINED CONSCIOUSNESS. HE WAS ADMITTED IN THE HOSPITAL FOR 2 DAYS. PATIENT WAS NOT GIVEN A DIAGNOSIS AND HIS DIABETES REGIMEN WAS NOT CHANGED BECAUSE OF THE INCIDENT. THERE WAS NO MISUSE OF THE PRODUCT AND THE BATTERIES DID NOT NEED TO BE REPLACED. THE LAST READING THE PATIENT OBTAINED ON HIS METER WAS TWO DAYS BEFORE THE ALLEGED ISSUE BEGAN AND OBTAINED A 170 MG/DL. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER POWERING OFF DURING USE, THE PATIENT WAS UNABLE TO TEST, DEVELOPED SYMPTOMS, AND HAD TO BE HOSPITALIZED AND TREATED FOR 2 DAYS FOR A BLOOD GLUCOSE OF 450 MG/DL.

    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 41 YR Life Threatening| R