BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6676221 · Received June 29, 2017

    Report

    Report Number
    3005862821-2017-00055
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    May 30, 2017
    Report Date
    May 30, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 RETURNED STRIPS (STRIP LOT NUMBER: D161019-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/59 MG/DL, FOR LEVEL HIGH WERE 267/259 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. PASS . WE TESTED THE SUSPECTED METER WITH RETAIN STRIPS (SAME BATCH AS PATIENT'S RETURNED STRIPS, LOT NUMBER: D161019-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/64 MG/DL; FOR LEVEL HIGH WERE 268/269 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 # 51850-3265445), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 01/25/2017. THE STRIP LOT # D161019-1 WAS MANUFACTURED ON 10/19/2016 AND EXPIRED IN 10/19/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS(SAME PATIENT'S STRIP BATCH) FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56/64 MG/DL; FOR LEVEL HIGH WERE 229/229 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 3005862821-2017-00055 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(6) 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 12:00 PM AFTER THE END USER RECEIVED INCONSISTENT BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS UNRESPONSIVE AND COULD NOT GET OUT THE BED. HER BLOOD GLUCOSE AT THE TIME OF THE MEDICAL EVENT WAS 59 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 37 MG/DL. IV FLUID WERE ADMINISTERED BY THE PARAMEDICS TO HELP STABILIZE HER BLOOD GLUCOSE LEVEL. THE END USER WAS NOT TRANSPORTED TO THE ER AND NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458978 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 75300-D161019-1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention AMLODIPINE-BENAZEPRIL 10-20 MG| LEVEMIR - 65 UNITS IN THE MORNIN| MELOXICAM 15MG| PRAVASTATIN SODIUM 40MG| TRIAMTERENE / HYDROCHLOROTHIAZIDE 37.5MG - 25MG