BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1984289 · Received February 10, 2011

    Report

    Report Number
    2939301-2011-01299
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    February 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (11/20/2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER WAS FOUND TO FUNCTION PROPERLY. NO ERROR WAS OBSERVED DURING TESTING. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS ALSO BEEN RETURNED; HOWEVER, TESTING WAS NOT PERFORMED SINCE THE PRODUCT WAS EXPIRED AT THE TIME OF THE COMPLAINT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS DISPLAYING THE "ERROR 4" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN DATE/TIME PRIOR TO CONTACTING LFS. IT IS NOT KNOWN IF THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR WHETHER HE MADE ANY CHANGES TO HIS DIABETES REGIMEN AT THE TIME THE ALLEGED ISSUE BEGAN. AT AN UNKNOWN DATE/TIME, THE PATIENT CLAIMED HE WAS NOT FEELING GOOD AND WAS SHAKY PRIOR TO THE START OF THE ALLEGED ISSUE. IN SPITE OF HIS SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER HAD BEEN USED BEFORE BY THE PATIENT AND THE PATIENT'S PROCESS FOR TESTING WAS CORRECT; HOWEVER THE ALLEGED ERROR MESSAGE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT FELT SYMPTOMATIC PRIOR TO THE START OF 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. 3052324

    Patients

    Seq Age Sex Outcome Treatment
    1 108 YR