BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 658138 · Received December 19, 2005

    Report

    Report Number
    2939301-2005-05781
    Event Type
    Malfunction
    Date Received
    December 19, 2005
    Report Date
    December 9, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A 196 MG/DL AND A 396 MG/DL WITHIN 10 MINUTES FROM ONE ANOTHER. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE CONTROL SOLUTION HAD BEEN OPENED LESS THAN THE DISCARD DATE. THE TEST STRIPS FAILED TWICE USING THE CONTROL SOLUTION 139, 144 (102-138). CUSTOMER CARE AGENT (CCA) HAD THE PATIENT OPEN A NEW VIAL OF TEST STRIPS AND THE TEST STRIPS FELL WITHIN RANGE 135 (102-138).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2592351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN