BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7181472 · Received January 11, 2018

    Report

    Report Number
    3005862821-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    November 24, 2017
    Report Date
    November 29, 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
    PR, 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. 1. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON NOV. 02,2016 2. THE STRIP LOT # D160704-1 WAS MANUFACTURED ON JULY 04, 2016 AND EXPIRED ON JULY 04, 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . 3. WE TESTED THE RETAIN STRIPS(LOT#D160704-1 SAME AS PATIENT'S STRIPS) FROM OUR WAREHOUSE WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/55 MG/DL; FOR LEVEL HIGH WERE 218/221 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 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 1:00 PM AFTER THE USER ALLEGED THAT HE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER STATED THAT HE FELT TIGHTNESS IN HIS CHEST ACCOMPANIED WITH A BLOOD GLUCOSE READING OF "HI". THE END USER WAS IMMEDIATELY TAKEN TO THE ER FOR FURTHER EVALUATION. UPON ARRIVAL TO THE ER A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE HOSPITALS METER AND THE READING WAS 108 MG/DL. NO TREATMENTS OR TEST WERE PERFORMED AND AFTER 6 HOURS IN THE ER THE END USER WAS DISCHARGED. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25575 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160704-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ATORVASTATIN 80 MG| ENALAPRIL 20 MG| MEFORMIN 500 MG| SIMVASTATIN