BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1984156 · Received February 10, 2011

    Report

    Report Number
    2939301-2011-01278
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 (B)(4) ON (B)(6) 2011 ALLEGING AN ERROR 5 MESSAGE ON HER ONE TOUCH VITA METER. THE PATIENT MENTIONED THAT HER METER WAS WORKING AND WHEN SHE SWITCHED TO NEW TEST STRIPS THEY HAVE BEEN GIVING HER AN ERROR 5 MESSAGE ON (B)(6) 2011. THE PATIENT CLAIMS THAT DUE TO THE ALLEGED ISSUE, SHE WAS VERY ANXIOUS AND WAS "HIGH" AND FELT DEHYDRATED ON (B)(6) 2011. THE PATIENT SPOKE TO HER PHYSICIAN AND HE ADVISED THAT IF SHE FEELS HER BLOOD GLUCOSE LEVELS ARE HIGH SHE WOULD HAVE TO TAKE AN EXTRA TABLET OF SOLOZA. SHE TOOK AN EXTRA TABLET OF SOLOZA ON (B)(6) 2011 DUE TO HER SYMPTOMS. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE PATIENT DID NOT HAVE ANY OTHER WAY OF TESTING HER BLOOD GLUCOSE. ISSUE WAS NOT RESOLVED. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 5 MESSAGE, SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH AN EXTRA TABLET OF SOLOZA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3000313

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R