BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2386012 · Received December 22, 2011

    Report

    Report Number
    2939301-2011-12593
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510 (K) # IS K001109.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING THAT THEIR ONE TOUCH ULTRA METER POWERS OFF DURING USE. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. DUE TO THE ALLEGED ISSUE, THE PATIENT HAS BEEN UNABLE TO TEST AND ON (B)(6) 2011, THE PATIENT HAD DEVELOPED SYMPTOMS OF FEELING SWEATY. THE PATIENT SELF-TREATED WITH GLUCOSE TABLETS AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED AND THERE WAS NO EVIDENCE OF ANY MISUSE OF THE PRODUCT. BASED ON TROUBLESHOOTING, THE BATTERY DID NOT NEED TO BE REPLACED. THE ALLEGED ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT WORKING, THEY WERE UNABLE TO TEST AND DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH GLUCOSE TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3161560

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R