BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7012486 · Received November 9, 2017

    Report

    Report Number
    3005862821-2017-00120
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 7, 2017
    Report Date
    October 7, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OKB TESTED THE STANDBY CURRENT TEST IS 1.5. A. THE CRITERIA IS <55.A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D160802-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/61 MG/DL, FOR LEVEL HIGH WERE 249/239 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 TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER:D160802-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/58 MG/DL; FOR LEVEL HIGH WERE 257/260 MG/DL. THE 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 PDC ON 07/19/2013. THE STRIP LOT # D160802-1 WAS MANUFACTURED ON 08/02/2016 AND EXPIRED IN AUGUST 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME PATIENT'S BATCH FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/66 MG/DL; FOR LEVEL HIGH WERE 242/237 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00120 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON NOV. 16, 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 5:30 PM AFTER THE END USER RECEIVED VARIOUS LOW RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER WAS SWEATING AND CONFUSED ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 90 MG/DL. THE PARAMEDICS WERE CALLED AND ONCE THEY ARRIVED A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 60 MG/DL. THE PARAMEDICS STATED THAT THE PRODIGY DIABETES METER WAS INACCURATE AND THE READING WAS OFF BY 30 MG/DL. THE END USER WAS GIVEN AN IV FLUID ALONG WITH A SUGARY DRINK TO ASSIST IN RAISING HIS BLOOD GLUCOSE LEVEL. THERE WAS NO NEED TO TRANSPORT THE END USER 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
    794387 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160802-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention CRESTOR| FERROUS SULFATE| HUMALOG 75/25| METOPROLOL| PLAVIX