BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1933047 · Received December 20, 2010

    Report

    Report Number
    2939301-2010-10870
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 17, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K082513. 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 FRANCE ON (B)(6) 2010 ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH VITA METER. THE PATIENT NOTICED THE ALLEGED INACCURATE READINGS ON THE METER 3 WEEKS AGO. SHE HAD TESTED AND OBTAINED A 151 MG/DL AND A 173 MG/DL LESS THAN 20 MINUTES FROM ONE ANOTHER. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION AND "COLD" IN HER BACK. DUE TO THE SYMPTOMS, THE PATIENT VISITED HER PHYSICIAN AND HE CHANGED HER MEDICATION. HE HAD REMOVED AMARYL (5MG) FROM HER DAILY REGIMEN. THE PATIENT WAS NOT TESTED ON THE PHYSICIAN'S METER. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE INACCURATE READINGS SHE HAD OBTAINED ON HER METER, SHE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HER PHYSICIAN CHANGED HER DIABETES MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2986314

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R