BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 665227 · Received January 17, 2006

    Report

    Report Number
    2939301-2006-00136
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    December 23, 2005
    Report Date
    January 6, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006 THE LAY PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS PROMPTING THE APPLY SAMPLE ICON AND HE COULD NOT OBTAIN A METER READING. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT IN JAN, 2006 TO OBTAIN AND VERIFY INFO. THE PT SAID THAT ABOUT TWO WEEKS AGO HE TOOK HIS USUAL FIXED DOSES OF AM INSULIN: LANTUS INSULIN 35 UNITS AND HUMALOG 5 UNITS. HE DID NOT RECALL THE AM RESULT HE OBTAINED ON THE METER. IN THE EVENING, AROUND 5:30 PM, HE FELT "WEIRD" AND HIS LIP WAS TREMBLING. HE ATTEMPTED TO TEST WITH THE METER; THE APPLY SAMPLE PROMPT AND ERROR 4 APPEARED. HE CALLED EMT. EMT ARRIVED WITHIN A FEW MINUTES AND OBTAINED A RESULT OF 46 MG/DL ON THE EMT METER. EMT'S GAVE THE PT A TUBE OF ORAL GLUCOSE AND TOOK HIM TO THE ER. HIS BLOOD GLUCOSE WAS MONITORED IN THE ER AND HE WAS RELEASED TO HOME THAT EVENING. THE CUSTOMER SERVICE AGENT (CSA) WALKED THE PT THROUGH TESTING WITH A NEW TEST STRIP AND THE TEST STARTED. THE CSA WALKED THE PT THROUGH A CONTROL SOLUTION TEST; THE RESULT OF 126 MG/DL FELL WITHIN THE CONTROL SOLUTION RANGE OF 102-138 MG/DL. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED AS AN ADVERSE EVENT BECAUSE THE PT WAS UNABLE TO OBTAIN A RESULT WHEN HE FIRST EXPERIENCED SYMPTOMS AND HIS TREATMENT OF HYPOGLYCEMIA WAS DELAYED UNTIL THE ARRIVAL OF EMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2566512

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R