BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1948941 · Received January 5, 2011

    Report

    Report Number
    2939301-2011-00173
    Event Type
    Injury
    Date Received
    January 5, 2011
    Report Date
    December 16, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL. THE PATIENT MENTIONED THAT SHE OBTAINED A HIGH READING ON HER METER COMPARED TO THE LAB; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE TIME DIFFERENCE WAS BETWEEN 10-30 MIN APART. THE PATIENT MENTIONED SOON AFTER TESTING SHE DEVELOPED SYMPTOMS OF FEELING SHAKY. THE PATIENT DID NOT RECEIVE ANY TREATMENT DUE TO THE ALLEGED ISSUE. THE PATIENT WAS UNABLE/UNWILLING TO PROVIDE INFORMATION ABOUT THE TESTING SUPPLIES. PRODUCTS WERE REPLACED. ALTHOUGH READINGS WERE NOT PROVIDED, THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO AN ALLEGED HIGH READING, SHE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3038836

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening