BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2377446 · Received December 15, 2011

    Report

    Report Number
    2939301-2011-12336
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    December 11, 2011
    Report Date
    December 12, 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

    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.THE 510 (K) # IS K082513.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING THAT HE HAD OBTAINED A LOW TEMPERATURE MESSAGE ON HER ONE TOUCH VITA METER. THE PATIENT MENTIONED THAT ON (B)(6) 2011, SHE HAD LEFT HER METER OUTSIDE IN LOW TEMPERATURE WHILE SHE WAS WORKING OUTSIDE. SHE ATTEMPTED TO TEST AND WAS UNSUCCESSFUL AND AROUND 12:00AM, SHE HAD DEVELOPED SYMPTOMS OF FEELING DIZZY AND SWEATY. SHE THEN SELF-TREATED WITH FOOD/DRINK. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. SHE DID NOT ATTEMPT TO TEST ON ANOTHER DEVICE. SHE CLAIMED THAT WHEN SHE BROUGHT THE METER BACK TO "NORMAL" TEMPERATURE, SHE WAS SUCCESSFUL IN OBTAINING A BLOOD GLUCOSE READING. THE ALLEGED ISSUE WAS RESOLVED, VIA EDUCATING THE PATIENT ABOUT THE TEMPERATURE RANGE FOR THE METER. THE METER WAS WORKING FINE. METER WAS WORKING ACCORDING TO THE OWNER'S BOOKLET. THE METER WAS NOT REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE LOW TEMPERATURE MESSAGE ON THE METER, SHE WAS UNABLE TO TEST, DEVELOPED SYMPTOMS 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. 3143570

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R