BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA ENHANCED METER

    MDR report key: 2412422 · Received January 12, 2012

    Report

    Report Number
    2939301-2012-00477
    Event Type
    Injury
    Date Received
    January 12, 2012
    Report Date
    January 10, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510 (K) # K082513. INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) ON (B)(6) 2012 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH VITA ENHANCED METER. THE PATIENT MENTIONED SOMETIME AT THE END OF (B)(6) 2011 TO (B)(6) 2011 AROUND 4:30PM SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 150 MG/DL WHICH SHE FELT WAS ACCURATE. APPROXIMATELY 30 MINUTES LATER SHE DEVELOPED SYMPTOMS WHERE HER KNEES WERE SHAKING, FELT WEAK AND ACCELERATED HEART BEAT. SHE ATE SOME BISCUITS AND A PIECE OF SUGAR. SHE FELT BETTER SOON AFTER TREATMENT. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. PRODUCTS WERE REPLACED AND A REPLACEMENT METER WAS SENT TO THE PATIENT. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, SHE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD AND FELT BETTER SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3214824

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R