BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 468982 · Received June 23, 2003

    Report

    Report Number
    2939301-2003-04051
    Event Type
    Malfunction
    Date Received
    June 23, 2003
    Report Date
    June 16, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED LFS IN 2003 ALLEGING THAT THEIR METER WAS READING INACCURATELY HIGH. MEDICAL AFFAIRS SPECIALIST SPOKE WITH PT THE NEXT DAY TO OBTAIN ADDITIONAL INFO. PT EXPLAINED THAT THEY OBTAINED A "210 MG/DL" AT 6:30 AM. PT PROCEEDED TO TAKE 4 UNITS OF HUMALOG AND 18 UNITS OF NPH. THEY WERE NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS AT THE TIME. DUE TO THE "210 MG/DL", PT DECIDED TO EAT FEWER CARBOHYDRATES THAN NORMAL. APPROXIMATELY FIVE AND HALF HOURS LATER, PT STARTED FEELING SLEEPY, SWEATY, DISORIENTED, WITH SHAKY LEGS, SEEING SPOTS AND EVENTUALLY BLACKED OUT. PT EXPLAINED THAT SPOUSE FED THEM A TUBE (.68 OZ) OF CAKEMATE DECORATING GEL. PT DID NOT RECEIVE ANY MEDICAL CARE FROM A HEALTHCARE PROFESSIONAL. THE NEXT BLOOD GLUCOSE TEST WAS PERFORMED AT 5:45 PM. A RESULT OF "277 MG/DL" WAS OBTAINED ON THE REPORTED METER. PT REPORTED THAT THEIR TEST STRIPS HAD BEEN PEELING UPON INSERTION INTO THE METER. PT STATED THAT THEY HAD BEEN EXPERIENCING THE PEELING STRIPS WITH MANY DIFFERENT VIALS FOR AN UNK LENGTH OF TIME. PT REPORTED THAT THE TEST STRIP PEELED WHEN PT OBTAINED THE "210 MG/DL" READING THE DAY OF THE INCIDENT. THE CUSTOMER SERVICE REP WALKED PT THROUGH A CONTROL SOLUTION TEST, WHICH FELL OUTSIDE THE ACCEPTED RANGE (193/109-148). THERE IS NO EVIDENCE TO SUGGEST THAT THE PT SUFFERED THE ADVERSE EVENT DUE TO THE METER. PT OBTAINED A READING AND TOOK THE PRESCRIBED AMOUNT OF INSULIN (NO EXTRA UNITS), HOWEVER, PT DECIDED ON THEIR OWN TO EAT FEWER CARBOHYDRATES DUE TO THE "210 MG/DL" READING. FIVE AND HALF-HOURS LATER THEY EXPERIENCED WHAT SEEMED TO BE HYPOGLYCEMIC SYMPTOMS, HOWEVER, THEY DID NOT PERFORM A TEST UNTIL 5 HOURS AFTER THEY EXPERIENCED SYMPTOMS. THE CUSTOMER SERVICE REPLACED THE METER AND CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 1021733

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR