BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2116977 · Received June 8, 2011

    Report

    Report Number
    2939301-2011-04714
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 (LFS) (B)(6) ON (B)(6) 2011, ALLEGING THAT THEIR ONE TOUCH VITA METER POWERS OFF DURING USE. THE PATIENT MENTIONED THAT SHE NOTICED THE ALLEGED ISSUE APPROXIMATELY ONE WEEK AGO. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE. ON (B)(6) 2011, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SWEATY AND SHAKY. THE PATIENT THEN TESTED ON A FRIEND'S VITA METER AND OBTAINED A 3.8 MMOL/L AND SELF-TREATED WITH FOOD/DRINK. THE PATIENT FELT BETTER AFTER TREATMENT. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE BATTERIES NEEDED TO BE REPLACED BASED ON THE OWNER'S BOOKLET; HOWEVER, THE PATIENT DID NOT HAVE A REPLACEMENT BATTERY WITH THEM WHILE TROUBLESHOOTING WITH THE CUSTOMER CARE ADVOCATE (CCA). THERE WAS NO MISUSE OF THE PRODUCT AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R