BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 286534 · Received July 18, 2000

    Report

    Report Number
    2939301-2000-00579
    Event Type
    Injury
    Date Received
    July 18, 2000
    Date of Event
    June 13, 2000
    Report Date
    June 14, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT'S PARENT CONTACTED LIFESCAN TO REPORT CHARACTERS MISSING ON THE PT'S TOUCH PROFILE METER. PT HAD REPORTEDLY RETURNED FROM A TRIP ON 06/11 STATING THAT "SOME NUMBERS ARE NOT ON THE MACHINE. SOMEBODY BROKE MY METER." THE MORNING RESULT OF 06/11 WAS "57." PT BEGAN FEELING WEAK AND DEHYDRATED AND WAS TAKEN TO THE EMERGENCY ROOM AROUND 12/P. UPON ARRIVAL, THE BLOOD GLUCOSE WAS 600 MG/DL. PT WAS GIVEN SALINE INTRA-VENOUS AND AN INSULIN SHOT AND DISCHARGED THE SAME DAY. PT FELT FINE THE FOLLOWING DAY. ON 06/13, PT BEGAN VOMITING AT 5:30/A, AN 8/A READING WAS "57" MG/DL, NO INSULIN GIVEN. PT WAS TAKEN TO THE DR'S OFFICE AT 9:30/A WHERE THE DR'S ONE TOUCH READ 517 MG/DL. PT WAS TREATED WITH 10U NPH AND 6R PLUS 5 MORE UNITS OF R BY PT'S PARENT WHILE IN THE DR'S OFFICE AND WAS LATER TAKEN TO THE HOSP. AT THE HOSP, PT WAS GIVEN INTRA-VENOUS ANTIBIOTICS AND ADMITTED FOR DIABETIC KETO-ACIDOSIS. NO OTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R