BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH II

    MDR report key: 167513 · Received May 6, 1998

    Report

    Report Number
    MW1013773
    Event Type
    Other
    Date Received
    May 6, 1998
    Report Date
    May 5, 1995
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR USES LIFESCAN ONE TOUCH II TO TEST THEIR SUGAR. THEY REPORT HAVING COMPLAINED ON 2 OCCASIONS ABOUT THE GREAT VARIATIONS OF READINGS. THE FIRST TIME CO SENT RPTR SOME TEST EQUIPMENT TO CHECK OUT THE UNIT. IT TESTS OUT JUST FINE. THIS LAST TIME CO SENT RPTR A NEW UNIT "PROFILE" & BY PHONE CO & RPTR TESTED BOTH UNITS OUT. RPTR TRIED TO NO AVAIL TO TELL CO "IT IS NOT A PROBLEM WITH THE TEST UNITS BUT RATHER A PROBLEM WITH THE TEST TAPES. EVERY TIME I OPEN A NEW VIAL OF TAPES I DO A DOUBLE TEST. I TAKE MY FIRST TEST WITH THE LAST REMAINING TAPE & THEN WITHIN A MIN RETEST WITH THE NEW TAPE. I CHECK DATES TO BE SURE THE ARE CURRENT. APRIL 14, 1998 I DID THIS PROCEDURE-OLD READING WAS 98-NO MEDICATION NEEDED. THE NEW READING WAS 178. AN 80 POINT DIFFERENCE & 50 POINTS ABOVE THE HIGH AVERAGE OF THESE TAPES." RPTR TAKES 12 MEDICATIONS & 3 VITAMINS DAILY-OF WHICH 2 PILLS ARE FOR SUGAR. NOW ON 2 OCCASIONS TRUSTING THESE READINGS, RPTR HAS TAKEN THEIR GLYNASE 3MG & WOUND UP WITH A VERY LOW SUGAR READING, WHICH RPTR DISCOVERED WHEN THEY RETOOK IT, WHEN THEY FELT DIZZY & FAINT. "I CANNOT TRUST THESE READINGS. THE OTHER MORNING, READ 144. IF IT'S 80 POINTS TOO HIGH & I TAKE A PILL THIS COULD BE DISASTEROUS. WAS IT REALLY 144 OR "64" (BELOW NORMAL), NO MEDICATION NEEDED?" "EVERY TIME", ABOUT MONTHLY RPTR PURCHASES THESE TEST STRIPS. THEY HAVE A DIFFERENT CODE WHICH RPTR CHECKS & RESETS THE TESTER FOR. EACH TIME THE TEST RANGE IS DIFFERENT. SUCH AS CODE 9 85-120 EXPIRATION 10-99 & CODE 9 92-129 EXPIRATION 3-2000. "THIS IS MY POINT OF CONTENTION-THESE MACHINES SHOULD ALWAYS TEST THE SAME, THE TAPES SHOULD ALWAYS BE THE SAME, YET IN THE SAME MIN, USUALLY BEFORE BREAKFAST WITH THE SAME MACHINE, BUT 2 DIFFERENT TAPES, & THE SAME BLOOD FROM THE SAME FINGER I HAVE VARIED AS MUCH AS 80 POINTS & DON'T KNOW WHETHER TO TAKE MY DIABETIC PILL OR NOT. I AM VERY CAREFUL AS TO HOW I DO THIS & VERY MUCH UP ON IT. IMAGINE SOMEONE ELDERLY NOT UNDERSTANDING & EITHER TAKING MEDICATION WHEN NOT NEEDED OR PASS ON THE DOSE & REALLY NEEDING IT & GOING INTO DIABETIC SHOCK!!" FOR THE RECORD, RPTR'S BLOOD IS DRAWN BY THEIR MD ABOUT EVERY 3 MOS & IF ANYTHING IS WRONG PT IS CALLED & TOLD ABOUT IT. THE LAST TEST WAS APR 6 & NO ONE CALLED SO RPTR ASSUMES THEIR SUGAR WASN'T TOO HIGH. "YET THESE TESTS THAT I DO AT HOME LEAVE ME UNSURE, FEELING UNSAFE & SKIPPING MEDICATIONS BECAUSE I KNOW I CANNOT TRUST THE RESULTS. I AM ABOUT TO CONTACT ONE OF THOSE TV PROGRAMS & SEE IF THEY WILL TEST THIS EQUIPMENT & SEE IF OTHERS HAVE THIS SAME PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH II BLOOD GLUCOSE METER & TEST STRIPS CFR LIFESCAN, INC. * *
    2 PROFILE BLOOD GLUCOSE METER & TEST STRIPS CFR LIFESCAN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other