BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1912016 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10390
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THREE DASHES ON HER ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT SHE FIRST NOTICED THE ALLEGED ISSUE ON (B)(6) 2010 AT 5:35PM. IMMEDIATELY AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY AND SWEATY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE METER HAD NEVER BEEN CODED BEFORE AND THE ALLEGED ISSUE WAS RESOLVED VIA TROUBLESHOOTING. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE TREE DASHES, SHE WAS UNABLE TO TEST AND IMMEDIATELY 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. 3045025

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening