BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 428195 · Received November 14, 2002

    Report

    Report Number
    2939301-2002-11203
    Event Type
    Injury
    Date Received
    November 14, 2002
    Report Date
    November 11, 2002
    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

    Description of Event or Problem · 1

    PATIENT'S FAMILY MEMBER CALLED LFS ALLEGING THAT THE PATIENT'S METER WAS READING INACCURATELY HIGH. MEDICAL AFFAIRS SPECIALIST SPOKE WITH PATIENT'S FAMILY MEMBER AND THE FOLLOWING INFORMATION WAS PROVIDED: A NEW VIAL OF TEST STRIPS WAS OPENED ON FRIDAY, IN 2002. A CONTROL SOLUTION TEST WAS PERFORMED WITH THE VERY STRIP FROM THE VIAL, WHICH FELL WITHIN RANGE. PATIENT OBTAINED NORMAL BLOOD GLUCOSE READINGS ON FRIDAY AND SATURDAY MORNING. PT ADMINISTERED THEIR NORMAL AMOUNT OF INSULIN SATURDAY MORNING. PATIENT TAKES 35 UNITS OF 75/25 IN THE MORNING AND 9 UNITS OF 75/25 IN THE EVENING. PATIENT'S INSULIN DOSAGE IS NOT DEPENDENT ON METER READINGS. IN THE AFTERNOON, WHILE AT A BALL GAME, AT APPROXIMATELY 12:50PM PATIENT STARTED FEELING FLU LIKE SYMPTOMS, LETHARGIC, UNRESPONSIVE, SLOBBERING, AND SEIZURE ACTIVITY. PATIENT OBTAINED A "171 MG/DL". PATIENT HAD LUNCH. AT 1:30 PM PATIENT OBTAINED A "182 MG/DL" AND AT 1:45 PM PT OBTAINED A "173 MG/DL". THEIR SYMPTOMS BECAME WORSE AND LOOKED AS THOUGH PATIENT WAS EXPERIENCING HYPOGLYCEMIA. THE AMBULANCE ARRIVED SHORTLY AFTER AND TREATED THEM WITH GLUCOSE, WHILE BEING RUSHED TO THE HOSPITAL. THE EMT DID NOT PERFORM A BLOOD GLUCOSE TEST. THE HOSPITAL METER READ SOMEWHERE LESS THAN "20 MG/DL". PATIENT WAS TREATED WITH IV GLUCOSE AND ADMITTED FOR THEIR DIABETES. PATIENT'S BLOOD GLUCOSE LEVELS WERE BETWEEN "25 MG/DL" AND "70 MG/DL" WHILE IN THE HOSPITAL. PATIENT WAS RELEASED WITH NORMAL BLOOD GLUCOSE LEVELS ON MONDAY. PATIENT'S FAMILY MEMBER CALLED LFS IN 2002 AND THE CUSTOMER SERVICE REPRESENTATIVE WALKED THEM THROUGH PERFORMING QUALITY CONTROL. BOTH CONTROL SOLUTION TESTS PERFORMED FAILED THE ACCEPTABLE RANGE (246 MG/DL & 269 MG/DL / 102-138 MG/DL). BASED ON THE LARGE DIFFERENCE BETWEEN THE METER READINGS AND THE HOSPITAL RESULT AND TWO-FAILED CONTROL SOLUTION TESTS, THE METER MAY HAVE BEEN READING INACCURATELY HIGH. THE CUSTOMER SERVICE REPRESENTATIVE REPLACED THE METER, TEST STRIPS AND CONTROL SOLUTION. PATIENT'S FAMILY MEMBER CONFIRMED THAT THEY HAD RECEIVED THE REPLACEMENTS AND EVERYTHING SEEMED TO BE WORKING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L