BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2802761 · Received October 24, 2012

    Report

    Report Number
    2939301-2012-12283
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (1/2/2013)-DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE LCD. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH A LINE GOING THROUGH THE DISPLAY ON THE PATIENT'S ONETOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT 3PM.,THE PATIENT MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY (TYPE NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. A COUPLE MINUTES PRIOR TO THE ALLEGED ISSUE, THE REPORTER CLAIMS THE PATIENT FELT A SYMPTOM OF SHAKY WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "59 MG/DL" WITH A BACKUP METER. THE PATIENT TREATED SELF WITH FOOD. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOM STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. 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. 3336534

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR