BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1900380 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09922
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    November 1, 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS/HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNKNOWN TIME AND DATE UNTIL HE/SHE STARTED TO NOTICE THE RESULTS MORE ON (B)(6) 2010. THE PATIENT STATED THE RESULTS OBTAINED WERE BETWEEN (B)(6) 2010. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "284, 128, AND 286 MG/DL" WITH THE SUBJECT METER AND "130, 70, AND 125 MG/DL" ON ANOTHER METER (MOTHER'S ONETOUCH ULTRALINK METER) PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN IF THE PATIENT MANAGES HIS/HER DIABETES WITH DIABETES MEDICATIONS OR IF THE PATIENT MADE ANY CHANGES TO HIS/HER DIABETES MANAGEMENT ROUTINE. AT AN UNSPECIFIED TIME AND DATE, THE PATIENT CLAIMED THAT HE/SHE FELT "HEART RACING" AND SHAKY PRIOR TO THE START OF THE ALLEGED ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THAT THE PATIENT TESTED ON AN APPROVED SAMPLE SITE AND THAT THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT WAS SYMPTOMATIC PRIOR TO THE ALLEGED ISSUE AND THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL TREATMENT FOR ACUTE COMPLICATIONS OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3025824

    Patients

    Seq Age Sex Outcome Treatment
    1