BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1832765 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07805
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K 061118.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 ULTRA MINI METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT ON (B)(6) 2010 AT AROUND 1:30PM, SHE ATTEMPTED TO TEST AND THE METER WOULD NOT POWER ON. IMMEDIATELY AFTER ATTEMPTING TO TEST SHE WAS SHAKING AND FELT NERVOUS. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. SHE WAS NOT TESTED ON ANOTHER DEVICE. WHILE TROUBLESHOOTING WITH THE REPRESENTATIVE, IT WAS NOTED THAT THE PATIENT WAS USING THE CORRECT VIAL OF TEST STRIPS. THE METER POWERED ON BY PRESSING THE POWER BUTTON AND THE METER POWERED ON WHEN INSERTING A TEST STRIP INTO THE METER. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE PRODUCT IS BEING USED. REPORTED ISSUE WAS RESOLVED VIA TROUBLESHOOTING. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY IMMEDIATELY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3000332

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R