BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6735204 · Received July 24, 2017

    Report

    Report Number
    3005862821-2017-00072
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 23, 2017
    Report Date
    June 26, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 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 RETURNED STRIPS (STRIP LOT NUMBER: D160720-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/64 MG/DL, FOR LEVEL HIGH WERE 252/266 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 (SAME STRIP AS PATIENT'S STRIPS, LOT NUMBER: D160720-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/56 MG/DL; FOR LEVEL HIGH WERE 232/230 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 (B)(6) DEPARTMENT AND SHIPPED TO PDC ON (B)(6) 2016. THE STRIP LOT # D160720-1 WAS MANUFACTURED ON 07/20/2016 AND EXPIRED IN 07/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP LOT #). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/61 MG/DL; FOR LEVEL HIGH WERE 230/228 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 3005862821-2017-00072 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 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 5:00 AM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST AND THE RESULT WAS 600 MG/DL ACCOMPANIED WITH PAIN IN HER ARMS, CHEST, SHOULDERS AND VOMITING. THE PARAMEDICS WERE CALLED AND THE END USER CONSUMED NITRO CHOLESTERIN WHILE WAITING FOR THEIR ARRIVAL. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 690 MG/DL. THE END USER RECEIVED AN UNKNOWN IV FLUID AND WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER THE END USER'S BLOOD GLUCOSE WAS 600 MG/DL AND FROM THERE AN INSULIN PUMP WAS ADMINISTERED TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVELS. AFTER 3 DAYS IN THE HOSPITAL THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 90 MG/DL AND INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517504 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160720-1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R ATORVASTATIN CALCIUM| DULOXETINE HCL 1 DAY| GABAPENTIN 100 MG| LEVOTHYROXINE SODIUM 1 A DAY| LORAZEPAM 1 MILLIGRAM| NITRO CHOLESTERIN| NOVOLOG| SUCRALFATE 4 A DAY