BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2042753 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02881
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011:THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS 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 WAS READING INACCURATELY HIGH COMPARED TO THE PATIENT'S FEELING/ NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT'S MOTHER BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT'S MOTHER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 3:30AM. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "86MG/DL" WITH THE SUBJECT METER. THREE MINUTES PRIOR TO THE ALLEGED ISSUE, THE PATIENT'S MOTHER INDICATED THE PATIENT HAD A SEIZURE. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS PRIOR TO THE ONSET OF HIS SYMPTOM, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT'S MOTHER TOOK IN RESPONSE TO THE PATIENT'S PREVIOUS BLOOD GLUCOSE RESULT (BEFORE GOING TO BED EARLIER THAT EVENING), AND IT IS ALSO NOT KNOWN IF THE PATIENT HAD ANY CHANGES TO HIS MEAL, ACTIVITY LEVEL, OR REGIMEN IN THE EVENING ON (B)(6) 2011. AT THE SAME TIME AFTER THE REPORTED METER ISSUE OCCURRED, THE PATIENT'S MOTHER ADMINISTERED A GLUCAGON INJECTION TO THE PATIENT AS TREATMENT. THE PATIENT DID NOT TEST HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY. THE PATIENT'S SYMPTOM STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE IS 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 7 YR