BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2220919 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07935
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    August 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A PROCESSOR FAILURE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED, THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 3PM. THE PATIENT REPORTEDLY MANAGES HER DIABETES USING INSULIN PUMP THERAPY (UNKNOWN TYPE/DOSE). THE PATIENT DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT ROUTINE WHEN SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE ON THE SUBJECT METER. AT APPROXIMATELY THE SAME TIME AS THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED THAT SHE WAS FEELING "DIZZY AND HAD A HEADACHE" BUT DENIED RECEIVING ANY TREATMENT FOR THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CORRECT TEST STRIPS WERE BEING USED. BASED ON THE ULTRALINK METER'S SPECIFICATIONS, THE BATTERIES DID NOT NEED TO BE REPLACED; HOWEVER, THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF A SERIOUS INJURY, NOR DID SHE RECEIVE MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3079802

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR