BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7181474 · Received January 11, 2018

    Report

    Report Number
    3005862821-2018-00002
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 10, 2017
    Report Date
    December 11, 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
    GA, 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 APRIL 20, 2017. THE STRIP LOT # D161129-1 WAS MANUFACTURED ON 11/29/2016 AND EXPIRED IN 11/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS (LOT#D161129-1, SAME AS PATIENT'S STRIPS) FROM OUR WAREHOUSE WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/55 MG/DL; FOR LEVEL HIGH WERE 246/237 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 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 AT 9:00 AM AFTER THE END USER ALLEGED THAT HE RECEIVED LOWER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER EXPERIENCED DIZZINESS AND PASSED OUT ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 45 MG/DL. THE PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 82 MG/DL. THE END USER WAS GIVEN AN IV OF FLUID TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE LEVELS AND IT WAS NOT NECESSARY TO TRANSPORT HIM TO THE ER. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25576 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161129-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention CARVEDILOL 6.25MG| CETIRIZINE 10MG| CLONIDINE 0.1MG| FUROSEMIDE 40MG| GABAPENTIN 400MG| HUMALOG 15UNITS 3 X DAILY| HUMULIN 65 UNITS AM| HYDROXYZINE 50MG| LOSARTAN 50MG| MIRTAZAPINE 15MG| PRAVASTATIN 10MG| PROMETHAZINE 12.5MG| TOPIRAMATE 50MG| VICTOZA 1.8 UNITS A DAY