BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVOCATE REDI-CODE BLOOD GLUCOSE METER

    MDR report key: 4902901 · Received June 29, 2015

    Report

    Report Number
    3004145393-2015-00001
    Event Type
    Other
    Date Received
    June 29, 2015
    Date of Event
    February 22, 2015
    Report Date
    June 25, 2015
    Manufacturer
    TAIDOC TECHNOLOGY CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K072039
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE USER, HOWEVER, WAS COMPLAINING THAT SHE GOT TEST STRIPS (ADVOCATE BMB-BA006A) THAT ARE NOT FOR USE WITH TAIDOC'S PRODUCT (TD-4223E). AFTER REVIEWING THE CASE, TAIDOC HAS FOUND OUT THAT THOSE TEST STRIPS ARE DISTRIBUTED BY SUNCOAST, A SUBSIDIARY OF PHARMA SUPPLY (TAIDOC'S FORMER DISTRIBUTOR) AND ARE MANUFACTURED BY OTHER SOURCE NOT AUTHORIZED BY TAIDOC. THE CASE HAS BEEN REPORTED TO FDA'S OFFICE OF COMPLIANCE IN ORDER TO HAVE FDA PUSH SUNCOAST AND PHARMA SUPPLY TO CONDUCT NECESSARY REACTIONS TO THOSE UNAUTHORIZED TEST STRIPS, ADVOCATE BMB-BA006A.

    Description of Event or Problem · 1

    A USER COMPLAINT AS FOLLOWING: "MY SON WAS ISSUED AN ADVOCATE REDI-CODE METER, MODEL TD4223E, IN (B) (6) OF 2014. WE GOT THIS PRODUCT VIA (B) (6) AS THIS IS THE ONLY WAY WE COULD GET IT BECAUSE HE HAS (B)( (6). WE ALSO RECEIVED STRIPS FROM THE SAME COMPANY. AND THEY COME EVERY MONTH IN THE MAIL. WE GET 3 BOXES OF STRIPS PER MONTH. WE HAVE BEEN GETTING THE RECALLED/WRONG STRIPS SINCE DAY ONE AND JUST TODAY FOUND OUT ABOUT IT. WE GET THE ADVOCATE BMB-BA006A STRIPS. IT SAYS SPECIFICALLY ON THE BOXES THAT THESE STRIPS ARE NOT MEANT FOR THE ADVOCATE REDI-CODE METER, MODEL TD4223E. MY SON IS BORDER LINE HYPOGLYCEMIC AND AT TIMES HAS GONE PRE-DIABETIC. WE HAVE BEEN MONITORING HIM TO SEE IF WE NEEDED TO DO FURTHER TESTING FOR DIABETES OR HYPOGLYCEMIA. THERE WERE FEW TIMES WE NEARLY TOOK HIM TO THE HOSPITAL BASED ON RESULTS GIVEN BY THIS DEVICE, AND THERE WERE A FEW TIMES WE DID NOT BASE ON THE RESULTS GIVEN BY THIS DEVICE. WE WERE ALSO ASKED TO MONITOR MY DAUGHTER WITH THE SAME DEVICE BY THE DOCTOR BECAUSE HER SUGAR HAD TESTED IN THE PRE-DIABETIC RANGE. MY SON IS (B) (6) DIABETES (TYPE LAND 2) AND HYPOGLYCEMIA, WHICH BOTH RUN HEAVILY IN MY FAMILY. AND I AM ALARMED THAT SUCH A MISTAKE WAS ALLOWED TO HAPPEN TO MY ONLY CHOICE OF PROVIDER FOR TESTING EQUIPMENT. I AM GRATEFUL THAT WE'VE NOT HAD ANY SERIOUS HEALTH ISSUES. BUT, WE ARE GOING TO BE DEMANDING A NEW METER AND STRIPS. WE ARE ALSO REPORTING THIS (B) (6), AND POSSIBLY GOING FURTHER WITH IT JUST TO GET THE "WORD OUT". WE DO NOT DESIRE A LAWSUIT. WE JUST WANT PEOPLE MADE AWARE SO THAT IF THIS HAS HAPPENED TO OTHERS, THEY CAN BE AWARE AND GET THE MATTER RESOLVED FOR THEMSELVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419633 ADVOCATE REDI-CODE BLOOD GLUCOSE METER GLUCOSE METER, GLUCOSE TEST TRIP NBW TAIDOC TECHNOLOGY CORPORATION TD-4223E

    Patients

    Seq Age Sex Outcome Treatment
    1