BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH GLUCOSE METER AND TEST STRIPS

    MDR report key: 3533234 · Received October 22, 2013

    Report

    Report Number
    MW5033556
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Date of Event
    July 27, 2013
    Report Date
    October 21, 2013
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXTREMELY QUESTIONABLE DIABETIC TESTING METER/STRIPS NUMBERS RUNNING 10-20 POINTS HIGHER THAN WITH ACCU-CHECK. GOT SWITCHED TO EASY-TOUCH, MHC MEDICAL PRODUCTS, LLC, (B)(4). CHANGE WAS MADE AFTER (B)(6) BECAUSE ACC-CHECK NO LONGER ON MEDICARE LIST. NUMBERS HAVE BEEN VERY QUESTIONABLE-RUNNING 10-20 POINTS HIGHER THAN OTHER BRAND. ALSO GOT SOME VERY LOW NUMBERS THAT COULD NOT BE RIGHT FROM THE WAY I FELT. (B)(6) 2003, CONTACTED COMPANY. RECEIVED 50 FREE TEST STRIPS, LANCETS, TEST SOLUTION. GOT A 22 WITH ONE STRIP BEFORE LUNCH ON SUNDAY, THEN A 103 ON OTHER HAND. (B)(6), IS NO LONGER HANDLING THIS EASY TOUCH BRAND BECAUSE OF HIGHER THAN NORMAL QUESTIONABLE TEST RESULTS FROM A LOT OF THEIR CUSTOMERS. BEGAN USING EASY TOUCH THE LAST WEEK OF (B)(6) 2013 METER S/N # (B)(4) STRIPS LOT PK17691901 EXP APR 2014. NEW SAMPLE SENT BY COMPANY IN (B)(4) EXP JUNE 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541209 EASY TOUCH GLUCOSE METER AND TEST STRIPS TEST STRIPS CGA MHC MEDICAL PRODUCTS, LLC PK17691901
    541210 EASY TOUCH GLUCOSE METER AND TEST STRIPS TEST STRIPS CGA MHC MEDICAL PRODUCTS, LLC PK17H309B1
    541248 EASY TOUCH GLUCOSE METER AND TEST STRIPS METER CGA MHC MEDICAL PRODUCTS, LLC S/N # M12KGO14060 PK17691901& PK17H309B1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other