BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7181473 · Received January 11, 2018

    Report

    Report Number
    3005862821-2018-00003
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 2, 2017
    Report Date
    December 5, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PDC ON 08/13/2015. THE STRIP LOT # D170221-1 WAS MANUFACTURED ON 02/21/2017 AND EXPIRED ON 02/21/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS (LOT#D170221-1, SAME AS PATIENT'S STRIPS) FROM OUR WAREHOUSE WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/53 MG/DL; FOR LEVEL HIGH WERE 232/227 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AFTER THE END USER ALLEGED THAT HIS PRODIGY DIABETES METER WAS NOT READING ACCURATELY. THE END USER WAS LETHARGIC ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 100 MG/DL. THE PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 46 MG/DL. THE END USER WAS GIVEN ORANGE JUICE, A PEANUT BUTTER AND JELLY SANDWICH ALONG WITH PIZZA TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE LEVELS. THERE WAS NO NEED TO TRANSPORT THE END USER TO THE ER ONCE HE RECEIVED TREATMENT. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25584 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D170221-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ATORVASTATIN 40MG| CARVEDILOL 6.25MG| CLOPIDOGREL 75MG| FUROSEMIDE 20MG| GABAPENTIN 300MG| LEVEMIR 12UNITS 2X A DAY| LISINOPRIL 2.5MG| NOVALOG 5MG| SPIRONOLACTONE 25MG