BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1911999 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10389
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 510 (K) # IS K061118. 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 THAT HER ONE TOUCH ULTRAMINI METER POWERS OFF DURING USE. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE PATIENT MENTIONED THAT A COUPLE OF HOURS LATER, THE PATIENT FELT DIZZY AND SWEATY. THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THERE WAS NO MISUSE OF THE PRODUCT. THE BATTERIES WERE ALREADY REPLACED. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3033047

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening