BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH II

    MDR report key: 83519 · Received April 11, 1997

    Report

    Report Number
    2939301-1997-00024
    Event Type
    Injury
    Date Received
    April 11, 1997
    Date of Event
    January 1, 1997
    Report Date
    April 11, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    H3 - CO IS UNABLE TO COMPLETE CO'S INVESTIGATION OF THE MDR INCIDENT DOCUMENTED IN CO'S INITIAL REPORT. THE METER WOULD NOT POWER ON DUE TO BROKEN AND SHORTED PINS. AT THIS POINT, CO'S INVESTIGATION OF THIS MATTER IS CLOSED. H6 - =METER WOULD NOT POWER ON, UNABLE TO INVESTIGATE.

    Description of Event or Problem · 1

    IN 1/97 (EXACT DATE UNK), THE PT (IDDM) WAS NOT FEELING WELL AND WAS ADMITTED TO THE HOSP FOR DIABETIC KETOACIDOSIS. HE HAD BEEN OBTAINING BLOOD GLUCOSE RESULTS FROM 200-300 MG/DL ON HIS METER PRIOR TO HOSPITALIZATION. UPON ADMISSION, HIS BLOOD GLUCOSE LEVEL WAS "OVER 800 MG/DL". HE WAS TREATED WITH IV INSULIN AND ANTIBIOTICS AND RELEASED AFTER 4 OR 5 DAYS. THE METER IS CLEANED EVERY "TWO WEEKS OR SO" WITH A DRY TISSUE. THE OWNER'S BOOKLET RECOMMENDS CLEANING ONCE A WEEK USING WATER TO CLEAN THE METER OPTICS. NO QUALITY CONTROL TESTS ARE PERFORMED. CALIBRATION STATUS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH II BLOOD GLUCOSE METER CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R