BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2028905 · Received March 24, 2011

    Report

    Report Number
    2939301-2011-02579
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 19, 2011
    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 (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READING ON THE PATIENT'S ONE TOUCH VITA METER. THE PATIENT MENTIONED THAT THE ALLEGED HIGH READINGS BEGAN ON (B)(6) 2011. THE PATIENT OBTAINED A 3:55 MG/DL AT 9:25 AM ON (B)(6) 2011. DUE TO THE ALLEGED HIGH READING, THE PATIENT TOOK AN INCREASE DOSAGE OF INSULIN (10 UNITS OF NOVOLOG). A FEW MINUTES LATER THE PATIENT HAD FAINTED DUE TO THE ALLEGED HIGH READINGS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT DUE TO THE ALLEGED ISSUE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, HE HAD TAKEN INSULIN AND A FEW MINUTES LATER HAD PASSED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3049194

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R