BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6735206 · Received July 24, 2017

    Report

    Report Number
    3005862821-2017-00070
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 17, 2017
    Report Date
    June 24, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 1.1A. 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: D160526-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 51/55 MG/DL, FOR LEVEL HIGH WERE 245/249 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 LOT AS PATIENT'S STRIP, LOT NUMBER: D160526-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 47/51 MG/DL; FOR LEVEL HIGH WERE 240/235 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) 2013. THE STRIP LOT # D160526-2 WAS MANUFACTURED ON 05/26/2016 AND EXPIRED IN 05/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS BATCH#D160526-2 WITH IN HOUSE METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56/56 MG/DL; FOR LEVEL HIGH WERE 219/229 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 3005862821-2017-00070 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

    PRODIGY DIABETES CARE RECEIVED A CALL ON (B)(6) 2017 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2017 @ 10:00AM. ENDUSER ((B)(6)) CALLED IN STATING THAT SHE RECEIVED A LOW BLOOD GLUCOSE READING ON HER PRODIGY METER. (B)(6) WAS EXPERIENCING SYMPTOMS OF SHAKING. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 78MG/DL. (B)(6)'S NORMAL GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 200MG/DL. (B)(6) STATED THAT SHE TOOK THE FOLLOWING MEDICATIONS PRIOR TO SEEKING MEDICAL ATTENTION: (B)(6), NOVO LOG INSULIN AND LONG ACTING INSULIN BASAGLARO. (B)(6) ALSO STATED THAT SHE CONSUMED FISH, GREEN BEANS, MASHED POTATOES, ICE CREAM AND ORANGE JUICE BETWEEN 8-9PM PRIOR TO SEEKING MEDICAL ATTENTION. PARAMEDICS WERE CALLED WITHIN 10-15 MINUTES AFTER THE EVENT. PARAMEDICS ARRIVED 2 MINUTES AFTER BEING CALLED. (B)(6) PERFORMED AN ADDITIONAL GLUCOSE TEST WITH HER METER WITH A RESULT OF 90 MG/DL. UPON ARRIVAL PARAMEDICS TESTED (B)(6)'S GLUCOSE LEVEL WITH THEIR METER WITH A RESULT OF 141MG/DL. (B)(6) WAS NOT TRANSPORTED BY PARAMEDICS TO ER NOR DID SHE GO ON HER OWN. NO ADDITIONAL DETAILS WERE GIVEN BY (B)(6). PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515560 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 D160526-2

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention AMLODIPINE-BENAZEPRIL10-20 MG| ATORVASTATIN 40 MG| HYDROCHLORIDE 25 MG| JENTADUETO| LEVOTHYROXINE 150 MG| LONG ACTING INSULIN BASAGLAR| NOVO LOG INSULIN| PANTOPRAZOLE SOD 40 MG