BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1891484 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09692
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Report Date
    October 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4); 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 THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6), 2010 AT 2:45PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "80 MG/DL" WITH THE SUBJECT METER AND "64 MG/DL" ON ANOTHER METER (UNKNOWN BRAND), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS MEETS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT DENIED TAKING ANY DIABETES MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF THE ALLEGED ISSUE, IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS/HER DIABETES MANAGEMENT ROUTINE. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED AT 2:15PM THAT DAY, HE/SHE WAS FEELING LIGHTHEADED AND DIZZY. THE PATIENT INDICATED, AT 2:50PM THAT SAME DAY, HE HAD A DOCTOR'S OFFICE VISIT. AT THE TIME OF THE DOCTOR'S OFFICE VISIT, HE WAS ADMINISTERED GLUCOSE TABLET/GLUCOSE GEL AND OBTAINED A READING OF "89 MG/DL" BY THE DOCTOR/CLINIC METER AT 3:15PM. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULT (S) FROM THE SUBJECT METER AND THAT THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT HAD BECOME SYMPTOMATIC PRIOR TO THE ALLEGED ISSUE. IN ADDITION, THERE IS NO EVIDENCE IN THE DELAY OF TREATMENT. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR