BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1882189 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09441
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010 AT 7:18AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "353 AND 465 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. ON AN UNSPECIFIED TIME AND DATE, THE PATIENT CLAIMED SHE FELT THIRSTY, TIRED, AND HAD A HEADACHE BEFORE THE ALLEGED ISSUE BEGAN. THE PATIENT INDICATED SHE DID NOT RECEIVE ANY MEDICAL TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE PATIENT'S TESTING PROCEDURE WAS CORRECT, THE RESULTS WERE FROM AN APPROVED SAMPLE SITE, AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THE CCA WAS NOT ABLE TO CONFIRM IF THE TEST STRIPS WERE EXPIRED, STORED IMPROPERLY, OR OPENED LONGER THAN THE DISCARD DATE SINCE THE PATIENT DID NOT HAVE TEST STRIPS AVAILABLE AT THE TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE ALLEGED ISSUE CORRELATED WITH THE SYMPTOMS AND THE PATIENT HAD BECOME SYMPTOMATIC PRIOR TO THE ALLEGED ISSUE. 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. 3043214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR