BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1972780 · Received January 28, 2011

    Report

    Report Number
    2939301-2011-00945
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 READINGS ON HER ONE TOUCH VITA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2011, AT AN UNSPECIFIED TIME, THE PATIENT OBTAINED A RESULT OF 140 MG/DL. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS AND TOOK AN INCREASE OF 4 UNITS OF INSULIN. IT IS UNKNOWN WHY THE PATIENT TOOK AN INCREASE DOSAGE OF INSULIN. APPROXIMATELY AN HOUR LATER, THE PATIENT FAINTED AND GOT UP ON HER OWN AND WENT AND TESTED HER BLOOD GLUCOSE AND OBTAINED A 70 MG/DL AND FELT BETTER 20 MINUTES LATER. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. A NORMAL READING FOR THE PATIENT IS AROUND 120 MG/DL. THE PATIENT WENT AND DID A METER TO LAB COMPARISON ON THE MORNING OF (B)(6) 2011. THE PATIENT OBTAINED A 123 MG/DL ON THE LFS METER AND AN 89 MG/DL IN THE LAB. THE PATIENT WAS NOT TREATED AT THE PHYSICIAN'S OFFICE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READING, SHE HAD TAKEN AN INCREASE DOSAGE OF INSULIN AND AN HOUR LATER FAINTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening