BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2188479 · Received August 3, 2011

    Report

    Report Number
    2939301-2011-06774
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 510 (K) # IS K073231. 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 THEIR ONE TOUCH ULTRALINK METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 7:00PM. DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNABLE TO TEST THEIR BLOOD GLUCOSE AND DID NOT TAKE ANY MEDICATION . A FEW HOURS LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING SWEATY, IRRITATED AND TIRED. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION OR CONTACTING THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE METER POWERED ON BY PRESSING THE POWER BUTTON; HOWEVER DID NOT POWER ON BY INSERTING THE TEST STRIP INTO THE METER. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWER ON, HE LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY BASED ON LFS DEFINITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3138514

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening