BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1915857 · Received December 6, 2010

    Report

    Report Number
    2939301-2010-10556
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    November 23, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510 (K) IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT'S HUSBAND CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S HUSBAND REPORTED THE ALLEGED ISSUE BEGAN WHEN THE PATIENT RECEIVED THE SUBJECT METER PRIOR TO CONTACTING LFS. THE HUSBAND REPORTED BLOOD GLUCOSE RESULTS OF "143 MG/DL" WITH THE SUBJECT METER AND AN UNSPECIFIED RESULT ON ANOTHER METER (TYPE UNKNOWN), PERFORMED AT AN UNSPECIFIED TIME OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE CANNOT BE DETERMINED FOR THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN IF THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR WHETHER THE PATIENT MADE ANY CHANGES TO HER DIABETES MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE. THE HUSBAND CLAIMED THE PATIENT WAS EXPERIENCING PAIN IN THE LEGS 4-6 MONTHS PRIOR TO THE START OF THE ALLEGED ISSUE; HOWEVER IT IS NOT KNOWN WHETHER THE PATIENT RECEIVED ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S HUSBAND WAS NOT ABLE TO PROVIDE THE CCA WHETHER THE PATIENT'S PROCESS FOR TESTING WAS CORRECT. THE PATIENT'S HUSBAND DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S SYMPTOM DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AND THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3019487

    Patients

    Seq Age Sex Outcome Treatment
    1