BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2114775 · Received June 6, 2011

    Report

    Report Number
    2939301-2011-04587
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819. 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 ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRASMART METER. THE PATIENT MENTIONED THAT THEY OBTAINED A RESULT OVER 200 MG/DL ON THEIR LFS METER ON (B)(6) 2011 AT AROUND 2:30PM. THE PATIENT DID NOT TAKE ANY ACTION AFTER OBTAINING THE ALLEGED HIGH READINGS. APPROXIMATELY AN HOUR ALTER THE PATIENT DEVELOPED SYMPTOMS OF FEELING LIGHTHEADED AND WAS SHAKY. THE PATIENT SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, THEY DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AN HOUR LATER AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3134378

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R