BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1833411 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07888
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109.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 AN ERROR 2 MESSAGE ON THE PATIENT'S ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 6:45 AM. THE PATIENT ATE MORE FOOD/DRINK AT 7:00AM. THE PATIENT MENTIONED THAT AROUND 10:30 AM SHE FELT SHAKY, BLURRED VISION AND FELT HYPOGLYCEMIC. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. WHILE TROUBLESHOOTING, THE METER DISPLAYED AN ERROR 2 WHEN POWERING THE METER ON. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 2 MESSAGE AND NOT BEING ABLE TO TEST, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 4.5 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3040722

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening