BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2791708 · Received October 15, 2012

    Report

    Report Number
    2939301-2012-12054
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 26, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS PROMPTING AN 'ERROR 3' MESSAGE WHEN HE WAS ATTEMPTING TO TEST HIS BLOOD GLUCOSE. ACCORDING TO THE OT ULTRALINK OWNER'S MANUAL, AN ERROR 3 INDICATES THAT THE BLOOD OR CONTROL SOLUTION SAMPLE WAS APPLIED PRIOR TO THE APPLY SAMPLE SYMBOL APPEARED ON THE DISPLAY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS UNKNOWN WHEN THE ALLEGED ISSUE FIRST STARTED. THE PATIENT REPORTED PRIOR TO THE START OF THE ALLEGED ISSUE, HE FELT 'CONFUSED AND SHAKY.' THE PATIENT REPORTED THE ERROR 3 MESSAGE WAS OCCURRING MORE FREQUENTLY THAN THE 'OTHER' ERROR MESSAGES. IT IS NOT KNOW WHAT THE PATIENT USES TO MANAGE HIS DIABETES. IT IS NOT KNOW IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS DUE TO THE ALLEGED ISSUE. THE PATIENT DID NOT RECEIVING ANY MEDICAL INTERVENTION IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE PATIENT WAS USING THE CORRECT TESTING PROCESS. THE CCA CONFIRMED THE ALLEGED ERROR MESSAGE OCCURRED WITH BLOOD. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT REPORTED BEING SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE. THEREFORE THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3337201

    Patients

    Seq Age Sex Outcome Treatment
    1