BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1910032 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10329
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING INACCURATE READINGS ON THEIR ONE TOUCH VITA METER. THE PATIENT MENTIONED THAT ON (B)(6), 2010 THEY OBTAINED THE FOLLOWING RESULTS: AT 9:36AM AT 207 MG/DL, 9:34AM AT 138 MG/DL, AT 9:31 AM A 133 MG/DL AND AT 9:03 AM A251 MG/DL. A FEW MINUTES AFTER TESTING THE PATIENT FELT DIZZY AND SWEATING. THE PATIENT ATE MORE FOOD/DRINK AND DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT TESTED ON ANOTHER METER; HOWEVER, IT IS UNKNOWN WHAT THE READING WAS ON THE OTHER DEVICE. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT'S TEST STRIPS WERE EXPIRED. USING EXPIRED TEST STRIPS MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. PRODUCTS WERE REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READINGS, HE SHORTLY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026617

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R