BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1857914 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08816
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 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 THAT HER ONE TOUCH ULTRA METER DOES NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN ON (B)(6) 2010. THE PATIENT ATE MORE FOOD/DRINK AFTER THE REPORTED ISSUE BEGAN. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF HEADACHE, BLURRY VISION, AND DRY MOUTH. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR SELF-TREAT DUE TO THE ALLEGED ISSUE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE BATTERIES DID NOT NEED TO BE REPLACED. THE REPORTED ISSUE WAS NOT RESOLVED. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON THEY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3010887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening