BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2233611 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08518
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (09/23/2011)-DEVICE EVALUATION: THE TEST STRIPS AND METER INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. HOWEVER, THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE BATTERY LEAKAGE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WOULD NOT POWER ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6), 2011 AT 3:30PM. THE PATIENT ADVISED THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP. THE PATIENT REPORTED THAT ON (B)(6), 2011 AT 4:00PM THAT SHE BECAME "THIRSTY". THE PATIENT CONFIRMED THAT WHEN THE METER WOULD NOT POWER ON, SHE DECREASED HER INSULIN. THE PATIENT CLAIMED THAT SHE DID NOT RECEIVE TREATMENT FOR THE ISSUE. DURING TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT STRIPS. THE CUSTOMER CARE ADVOCATE (CCA) NOTED THAT NO MISUSE WAS IDENTIFIED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT BY THE CCA. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, IT IS UNLIKELY THE PRODUCT ISSUE CONTRIBUTED TO THE REPORTED SYMPTOMS. HOWEVER, THE MALFUNCTION IS BEING REPORTED BECAUSE THE 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. 3025132

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR