BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2469239 · Received February 27, 2012

    Report

    Report Number
    2939301-2012-02017
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    February 8, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER DOES NOT TURN ON WHEN USING ANOTHER VIAL OF TEST STRIP WITH LOT NUMBER # 3052048. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012 AT 6:30PM. ACCORDING TO THE CSR'S DOCUMENTATION, JUST BEFORE THE REPORTED POWER ISSUE OCCURRED THE PATIENT REPORTEDLY WAS EXHIBITING SYMPTOMS OF TIREDNESS AND SLEEPINESS. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION/TREATMENT AFTER DISCOVERING THE REPORTED METER ISSUE. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERIES DID NOT NEED TO BE REPLACED PER OWNER'S BOOKLET RECOMMENDATION, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS USING THE CORRECT TEST STRIP. THE ALLEGED POWER ISSUE HOWEVER, REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052048

    Patients

    Seq Age Sex Outcome Treatment
    1