BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1051912 · Received May 23, 2008

    Report

    Report Number
    2939301-2008-00907
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    May 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CONTROL SOLUTION FOR THE LFS ULTRALINK METER WAS READING INACCURATELY LOW. ALTHOUGH IT WAS VERIFIED BY THE CUSTOMER SERVICE ADVOCATE (CSA) THAT THE CONTROL SOLUTION TEST WAS WITHIN RANGE, THE PRODUCT STILL HAD AN INACCURATE LOW CONTROL SOLUTION WHEN THE PATIENT CALLED LFS. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED BY THE CSA THAT THE TEST STRIPS WERE IN GOOD CONDITION, TESTING TECHNIQUE WAS CORRECT, AND PUNCTURE AREA WAS CLEANED PROPERLY. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2799456

    Patients

    Seq Age Sex Outcome Treatment
    1 Female