BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6506518 · Received April 19, 2017

    Report

    Report Number
    3005862821-2017-00033
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 16, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 10/27/2015. 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.

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2UA. THE CRITERIA IS <55UA. 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 59/54 MG/DL, FOR LEVEL HIGH WERE 259/260 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AROUND 4 AM AFTER THE END USER RECEIVED INCONSISTENT RESULTS FROM THEIR PRODIGY DIABETES GLUCOSE METER. THE END USER WAS LETHARGIC, INCOHERENT AND UNRESPONSIVE. HIS BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 130 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 39 MG/DL. THE PARAMEDICS ADMINISTERED AN IV WITH FLUIDS ALONG WITH A GLUCOSE PASTE TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE. NO FURTHER DETAILS WERE PROVIDED IN RELATION TO THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00033 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) ON 05/03//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287064 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention LANTUS 54 UNITS AT NIGHT| NOVOLOG 25 UNITS