BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7127890 · Received December 19, 2017

    Report

    Report Number
    3005862821-2017-00137
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 16, 2017
    Report Date
    November 16, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT TEST OF RETURNED METER, THE RESULT WAS 1.2A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 51/55 MG/DL, FOR LEVEL HIGH WERE 230/227 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.

    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 JUNE 16, 2016. 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00137 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON DEC. 20, 2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 4:00 AM WHEN IT WAS DISCOVERED THAT THE END USER'S PRODIGY METER WOULD NOT POWER ON EVEN AFTER CHANGING THE BATTERIES. THE END USER WAS DISCOVERED UNCONSCIOUS AND COULD NOT BE AWAKEN. THE CALLER WAS GOING TO ATTEMPT A BLOOD GLUCOSE TEST BUT THE METER WOULD NOT POWER ON. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 40 MG/DL. AN IV WAS ADMINISTERED TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL. THE END USER WAS TRANSPORTED TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS 50 MG/DL. ADDITIONAL IV FLUIDS WERE GIVEN ALONG WITH CONDUCTING A BLOOD AND URINE TEST. AFTER 3 HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 150 MG/DL. SHE WAS INSTRUCTED TO PURCHASE ANOTHER METER AND CHECK HER BLOOD GLUCOSE REGULARLY. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909722 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention