BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2137136 · Received June 22, 2011

    Report

    Report Number
    2939301-2011-05057
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THAT HER ONE TOUCH ULTRA METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNABLE TO TEST. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BEGAN TO SHAKE. THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE PATIENT WAS USING THE CORRECT VIAL OF TEST STRIPS. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE METER POWERED ON BY PRESSING THE POWER BUTTON. CUSTOMER SERVICE WALKED THE PATIENT THROUGH INSERTING A NEW TEST STRIP INTO THE METER AND THE METER POWERED ON. THE ALLEGED ISSUE WAS RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE WAS UNABLE TO TEST HER AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2887278

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening