BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1834219 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07915
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    September 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 5 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3016562

    Patients

    Seq Age Sex Outcome Treatment
    1