BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1884382 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09541
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2010 ALLEGING THAT THEIR METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT PRIOR TO TESTING ON (B)(6) 2010 AT 2:15PM, THE PATIENT FELT THIRSTY. THE PATIENT THEN ATTEMPTED TO TEST HIS BLOOD GLUCOSE AND NOTICED THAT THE METER WOULD NOT POWER ON. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON. THE BATTERIES DID NOT NEED TO BE REPLACED AND THE ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT'S OCCURRED PRIOR TO USING THE METER. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTED ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2965738

    Patients

    Seq Age Sex Outcome Treatment
    1