BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH II

    MDR report key: 99558 · Received June 20, 1997

    Report

    Report Number
    2939301-1997-00043
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    May 11, 1997
    Report Date
    June 20, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT DOCUMENTED IN CO'S INITIAL REPORT AND, AFTER TESTING THE DEVICE, HAS BEEN UNABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THAT THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, IMPROPER METER CLEANING/MAINTENANCE, OR SOME UNKNOWN ANOMALY. AT THIS POINT CO'S INVESTIGATION IS CLOSED.

    Description of Event or Problem · 1

    ON 5/11, THE PATIENT WAS FEELING ILL WITH VOMITING AND EXTREME THIRST FOR WHICH HE CONSUMED "6 20OZ. DIET 7-UPS." BECAUSE HE WAS FEELING SO BAD, HE CALLED AN AMBULANCE (TIME UNK). THE PARAMEDIC'S OBTAINED A BLOOD GLUCOSE RESULT OF HIGH ON THEIR ACCUCHECK METER. TWO HOURS PRIOR TO CALLING THE AMBULANCE, THE PATIENT TESTED ON HIS ONE TOUCH II METER WITH A RESULT OF 219 (ANOTHER ONE TOUCH II METER, KEPT IN HIS CAR READ 279 MG/DL AT THE SAME TIME). HE WAS TRANSPORTED TO THE HOSPITAL WHERE A LAB BLOOD GLUCOSE RESULT WAS 938 MG/DL. THE PATIENT WAS ADMITTED FOR DIABETIC KETOACIDOSIS AND TREATED WITH IV (UNK CONTENTS). NO OTHER METER RESULTS PRIOR TO THE DAY OF THE ALLEGED EVENT WERE REPORTED. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, ALCOHOL IS USED ON THE METER OPTICS. THE ONE TOUCH II OWNERS MANUAL STATES THAT USE OF ALCOHOL CAN DAMAGE THE METER OPTICS. THE METER WAS IN CALIBRATION ON 5/23, READING 76 WITHIN A RANGE OF 70-96.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R