BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1951047 · Received January 6, 2011

    Report

    Report Number
    2939301-2011-00213
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 26, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 A BATTERY INDICATOR ON HER ONE TOUCH ULTRAMINI METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN AT 4:00PM ON (B)(6), 2010. DUE TO THE ALLEGED ISSUE, THE PATIENT ATE LESS FOOD/DRINK. APPROXIMATELY AN HOUR LATER, SHE FELT SHAKY AND EXPERIENCED A HEADACHE. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE BATTERIES DID NOT NEED TO BE REPLACED AND THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THERE WAS NO MISUSE OF THE PRODUCT. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE AND THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE ENDED UP DEVELOPING 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. 3016212

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening