BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2110684 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04526
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K062195. 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 AN ISSUE WITH THE CAL CODE ON THEIR ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THEY FIRST NOTICED THE ALLEGED ISSUE ON (B)(6) 2011 AT AROUND 7:00PM. DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNABLE TO TEST THEIR BLOOD GLUCOSE. APPROXIMATELY 30 MINUTES LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING SWEATY, CLAMMY AND NERVOUS. THE PATIENT THEN SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH CHANGING THE CAL CODE AND THE REPORTED ISSUE WAS RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE THE ALLEGED ISSUE WITH THE CAL CODE, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3023542

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R