BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 449609 · Received July 31, 2002

    Report

    Report Number
    2939301-2002-08256
    Event Type
    Malfunction
    Date Received
    July 31, 2002
    Report Date
    July 23, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S METER WAS READING INACCURATELY LOW. THEY WERE NOT SURE IF THEY WERE HAVING HIGH OR LOW BLOOD GLUCOSE SYMPTOMS. THEY REPORTED OBTAINING "24 MG/DL, 38 MG/DL, 35 MG/DL, AND 34 MG/DL". THEY EXPLAINED THAT 10 MINUTES LATER THE EMS ARRIVED AT THEIR HOME. THE EMS TESTED THEIR BLOOD GLUCOSE LEVEL TO BE "187 MG/DL" ON THEIR METER. THEY RETESTED AND OBTAINED A "44 MG/DL" ON THEIR METER. THEY DID NOT REPORT ANY MEDICAL TREATMENT, WHICH SUGGESTED THAT THE "187 MG/DL" RESULT WAS MORE OF AN ACCURATE RESULT. THEY CLAIMED THAT THEY CLEANED THEIR METER AT LEAST 2 TIMES A WEEK, RUNS THE CHECK STRIP TEST 3 TO 4 TIMES A WEEK, AND RUNS THE CONTROL SOLUTION TEST 3 TIMES A WEEK. THE CCR WALKED THE CUSTOMER THOUGH A CONTROL SOLUTION TEST AND RECEIVED A RESULT OF "19 MG/DL" (RANGE 92-124). THE TEST STRIPS AND CONTROL SOLUTION WERE WITHIN EXPIRATION DATE. BASED ON THE INFORMATION PROVIDED, THE METER MAY HAVE BEEN READING INACCURATELY LOW DUE TO THE FAILED CONTROL SOLUTION TEST AND THE DIFFERENCES BETWEEN THE EMS AND THE CUSTOMER METER. CCR REPLACED THE METER AND TEST STRIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR