BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 569413 · Received January 12, 2005

    Report

    Report Number
    2939301-2005-00130
    Event Type
    Malfunction
    Date Received
    January 12, 2005
    Report Date
    January 10, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE PATIENT OBTAINED RESULTS OF 198, 389, 447, 251, 239, 274, 304, 319, 200, 360, AND 340 MG/DL ON THE REPORTED METER WHILE FEELING SHAKY. SEVERAL TESTS WERE ALSO CONDUCTED ON ANOTHER METER. THE TIME DIFFERENCE BETWEEN ALL THE RESULTS WAS NOT CERTAIN. THE FAMILY MEMBER TOOK PATIENT TO THE ER AFTER OBTAINING THE RESULT OF 389 MG/DL. A RESULT OF 140 MG/DL WAS OBTAINED ON THE ER METER. THE PATIENT WAS TREATED FOR DEHYDRATION WITH IV FLUIDS IN THE ER, AND THEN DISCHARGED TO HOME 6.5 HOURS LATER. A NORMAL BLOOD GLUCOSE RESULT WAS OBTAINED IN THE ER AND THE PATIENT WAS TREATED FOR DEHYDRATION. THERE IS NO INDICATION THAT THE PRODUCT CONTRIBUTED TO THE PATIENT EXPERIENCING INJURY OR MEDICAL INTERVENTION. THE CUSTOMER CARE REPRESENTATIVE (CCR) WALKED THE FAMILY MEMBER THROUGH A CONTROL SOLUTION TEST; HOWEVER, THE FAMILY MEMBER WAS UNABLE TO STATE THE CONTROL SOLUTION RESULT. THE METER KEPT SHUTTING OFF DURING TROUBLESHOOTING. THE FAMILY MEMBER DID NOT HAVE A REPLACEMENT BATTERY TO ATTEMPT CHANGING THE BATTERY. THE METER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2517765

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR