BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2062860 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03215
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 THAT THEY OBTAINED AN APPLY SAMPLE MESSAGE ON THEIR ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION THE PATIENT MENTIONED THAT THE FIRST NOTICED THE ALLEGED ISSUE IN (B)(6) 2010. SINCE THEN THE METER ALWAYS STAYED ON THE APPLY SAMPLE MESSAGE. THE PATIENT STOPPED TESTING HER BLOOD GLUCOSE DUE TO THE ALLEGE DISUSE. SHE DID CONTINUE TO TAKE HER DIABETES REGIMEN ON A REGULAR BASIS. APPROXIMATELY 5 MONTHS LATER, THE PATIENT DEVELOPED SYMPTOMS OF "HEAT", FEELING SWEATY AND "TREMORS". THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. SHE CLAIMS SHE DEVELOPED THESE SYMPTOMS TWICE OVER TWO WEEKS. THIS IS NOT THE FIRST TIME THE PATIENT WAS USING THE PRODUCT. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE APPLY SAMPLE MESSAGE ON HER METER, SHE STOPPED TESTING AND SEVERAL MONTHS LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3058617

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening