BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2042698 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02868
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 31, 2011
    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 K053529. 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 ULTRA 2 METER. THE PATIENT MENTIONED THAT THE ALLEGED HIGH READINGS BEGAN APPROXIMATELY THREE WEEKS AGO. THE PATIENT MENTIONED THAT HE HAD OBTAINED A 287 MG/DL AND A 291 MG/DL . THE PATIENT WAS COMPARING METER READINGS TO FEELINGS/ NORMAL RESULT(S). THE PATIENT HAD TAKEN 7 UNITS OF INSULIN AFTER OBTAINING A 287 MG/DL. AT AN UNSPECIFIED TIME AFTER TAKING THE INSULIN, HE BEGAN FEELING SHAKY, LIGHTHEADED AND CONFUSED. HE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING, HE HAD TAKEN INSULIN AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2901418

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening