BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2024044 · Received March 18, 2011

    Report

    Report Number
    2939301-2011-02362
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCT REQUESTED HAS NOT BEEN RECEIVED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/18/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS 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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS DISPLAYING THE "ERROR 4" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN TIME ON (B)(6) 2011. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY DIABETES MEDICATIONS. THE FOLLOWING DAY AT AN UNKNOWN TIME, THE PATIENT REPORTED EXERCISING AS A RESULT OF THE ALLEGED ISSUE. THREE DAYS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BECAME SHAKY AND NAUSEAS. IN SPITE OF HER SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE TEST STRIPS WERE IN GOOD CONDITION, THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, AND THE PATIENT WAS NOT A FIRST USER TO THE SUBJECT METER. THE ALLEGED ISSUE WAS RESOLVED THROUGH A BLOOD RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2998230

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening