BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2011040 · Received March 8, 2011

    Report

    Report Number
    2939301-2011-01984
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011, IT WAS NOTED THAT THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6) 2011, IT WAS NOTED THAT THE TEST STRIPS INVOLVED IN THIS CASE FAILED TESTING. ON PERFORMANCE TESTING WITH CONTROL SOLUTION THE RESULTS WERE FOUND TO FALL ABOVE THE LABELED RANGE. THEREFORE, THE COMPLAINT IS CONFIRMED. THE RETAIN STRIPS WERE ALSO TESTED AND NO FAULTS WERE FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH CONTROL READINGS ON HIS ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT HE RAN A QUALITY CONTROL TEST AND OBTAINED A 153, WHICH FELL OUT OF THE CONTROL RANGE ON THE VIAL OF TEST STRIPS ON (B)(6) 2011. DUE TO THE ALLEGED HIGH CONTROL READING, HE DECIDED TO DECREASE HIS DOSAGE OF MEDICATION. IT IS UNKNOWN WHETHER HE TESTED HIS BLOOD GLUCOSE AND WHAT THE READING WAS AT THE TIME OF THE EVENT. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, HE FELT SHAKY. HE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS USING THE CORRECT VIAL OF CONTROL SOLUTION. THE TECHNIQUE OF APPLYING THE CONTROL SOLUTION ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TEST STRIPS HAD NOT BEEN OPENED LONGER THAN THE DISCARD DATE. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A CONTROL TEST AND ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED INACCURATE CONTROL HIGH READING, HE LATER DEVELOPED SYMPTOMS 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. 3071251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening