BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1880768 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09354
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 (SUBMISSION 09/21/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE CONTROL SOLUTION AND TEST STRIPS INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) /2010, RESPECTIVELY. INVESTIGATION DID NOT CONFIRM THE ALLEGED COMPLAINT WITH BOTH RETURNED PRODUCTS; HOWEVER, A SECONDARY ISSUE WAS NOTED FOR THE CONTROL SOLUTION: THE CONTROL SOLUTION TEST READ BELOW EXPECTED RANGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE CONTROL SOLUTION TEST RESULTS ARE INACCURATELY HIGH OUT OF THE CONTROL SOLUTION RANGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED - FILE IS NOT REPORTABLE. THE DEVICE STOPPED ACTIVATING. IT WAS IMMEDIATELY REPLACED BY AN DEVICE WHICH WORKED FINE. NO HEMOSTATIS OR BLEEDING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3062278

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR