BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1781669 · Received August 3, 2010

    Report

    Report Number
    2939301-2010-06078
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON (B)(6), 2010 THE PATIENT WAS EXPERIENCING THE SYMPTOM OF SLURRED SPEECH. WHILE SYMPTOMATIC, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT ADMINISTERED SELF-TREATMENT BY DRINKING ORANGE JUICE; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT HAD CORRECTLY REPLACED THE BATTER AND THE TEST STRIPS WERE CORRECT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS BEGAN PRIOR TO THE METER ISSUE, THERE WAS NO DELAY IN TREATMENT, AND THE PATIENT DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER POWER ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3020384

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR