BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5942320 · Received September 12, 2016

    Report

    Report Number
    3005862821-2016-00067
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    July 22, 2016
    Report Date
    August 2, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(4) ON 04/16/2013. THE STRIP LOT #D151007-1 WAS MANUFACTURED ON 10/07/2015 AND EXPIRED IN 10/2017. OK BIOTECH RECEIVED NO OTHER COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON 08/02/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 10:30AM. PATIENT ((B)(6)) CALLED IN STATING HER METER WOULD POWER ON THEN ASK FOR BLOOD, BEGIN TO COUNT DOWN AND THEN SHUT OFF WITHOUT GIVING A READING. (B)(6) WAS EXPERIENCING SYMPTOMS OF SHAKINESS, SWEATING AND LOOPINESS. (B)(6)'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 80-90MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AFTER ATTEMPTING TO TEST (B)(6)'S GLUCOSE WITH THE PRODIGY METER. PARAMEDICS ARRIVED 3 MINUTES AFTER BEING CALLED. UPON ARRIVAL PARAMEDICS TESTED (B)(6)'S GLUCOSE WITH THEIR METER WITH RESULT OF 30MG/DL. APPROXIMATELY 3 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS GAVE (B)(6) A SANDWICH AND TRANSPORTED HER TO THE ER. (B)(6)'S BLOOD GLUCOSE READING UPON ARRIVAL AT THE E.R. WAS 38MG/DL. THE HOSPITAL GAVE (B)(6) AN IV, ORANGE, TURKEY SANDWICH AND PEANUT BUTTER CRACKERS. (B)(6)'S BLOOD GLUCOSE READING UPON DISCHARGE WAS 130MG/DL. (B)(6)'S TOTAL STAY IN THE HOSPITAL WAS 7 HOURS. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF THE SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594179 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151007-1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R ALBUTEROL PRO AIR HFA-2PUFFS AS NEEDED| ASPIRIN 81MG ONE DAILY| CALCIUM 600MG + VITAMIN D-3| FERROUS IRON SULFATE 325MG TWICE A DAY| FISH OIL 1000MG DAILY| FOSAMAX 70MG ONCE A WEEK| LIPITOR 80MG ONE EVERY EVENING| LISINOPRIL 10MG DAILY| LOPRESSOR 25MG TWICE DAILY| METFORMIN HC1 1000MG TWICE A DAY WHEN NEEDED| MULITIVIAMIN 1 PILL DAILY| OXYGEN 2 LPM| POTASSIUM CHLORIDE 20 MEQ DAILY| SINGULAIR 10 MG EVERY EVENING| SYMBICORT 160/4.5MCG/ACT 1PUFF TWICE A DAY| TORSEMIDE 20MG 3 TABLETS DAILY| VITAMIN B12 1000MCG ONCE A DAY| VITAMIN D3 2000MG ONCE A DAY| VITAMIN E 400UNITS 1 DAILY