BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2101233 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04354
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER POWERS OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS HIS BLOOD GLUCOSE FOUR TIMES A DAY AND MANAGES HIS DIABETES WITH INSULIN (VIA INSULIN PUMP). THE PATIENT'S MOTHER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 6:45PM. JUST PRIOR TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY WAS EXPERIENCING SYMPTOMS OF LOW BLOOD GLUCOSE (SPECIFYING TIREDNESS AND WEAK KNEES). AT THE SAME TIME FOLLOWING THE REPORTED METER ISSUE, THE PATIENT'S MOTHER INDICATED THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING A GLUCOSE DRINK; THE PATIENT REPORTEDLY FELT BETTER SEVERAL MINUTES LATER. THE PATIENT'S MOTHER CONFIRMED THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THAT THE SUBJECT METER'S BATTERIES WERE REPLACED AND THERE WAS NO MISUSE OF THE LFS PRODUCT. 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 IS ALSO NO EVIDENCE OF A DELAY IN TREATMENT. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR