BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2210988 · Received August 13, 2011

    Report

    Report Number
    2939301-2011-07344
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. 510(K) # IS K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (09/07/2011)-DEVICE EVALUATION: ON (B)(6) 2011 THE METER INVOLVED WITH THIS COMPLAINT WAS RETURNED TO LIFESCAN AND WAS EVALUATED BY THE PRODUCT ANALYSIS GROUP ON (B)(6) 2011. INVESTIGATION FOUND THAT THERE WAS AN EEPROM FAILURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FAILED DEVICE INVESTIGATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO HER ONETOUCH ULTRALINK METER DISPLAYING AN ERROR 1 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 7AM JUST PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT ABOUT 15 MINUTES PRIOR TO ATTEMPTING TO TEST ON THE SUBJECT METER SHE WAS EXPERIENCING SYMPTOMS OF "SHAKING." THE PATIENT DENIED TREATING HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT PRODUCT WAS NOT BEING USED FOR THE FIRST TIME. PER THE ONETOUCH ULTRALINK OWNER'S MANUAL, AN ERROR 1 MESSAGE MAY MEAN THERE IS A PROBLEM WITH THE METER. A REPLACEMENT METER WAS 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 WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. 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. 3111665

    Patients

    Seq Age Sex Outcome Treatment
    1