BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6970901 · Received October 24, 2017

    Report

    Report Number
    3005862821-2017-00107
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 21, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OKB TETEST THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.0¿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 IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/60 MG/DL, FOR LEVEL HIGH WERE 248/243 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. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, WE TESTED THE RETAIN STRIPS (SAME AS PATIENT'S REPORT BATCH: D160819-1) FROM OUR WAREHOUSE, AND TESTED IT WITH HIS RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/63 MG/DL; FOR LEVEL HIGH WERE 263/258 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 QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 11/17/2015. THE STRIP LOT # D160819-1 WAS MANUFACTURED ON 08/19/2016 AND EXPIRED IN 08/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OK BIOTECH TESTED THE RETAIN STRIPS OF LOT# D160819-1 WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/69 MG/DL; FOR LEVEL HIGH WERE 254/258 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 3005862821-2017-00107 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON OCT. 24,2017 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 9:30 AM AFTER THE END USER RECEIVED INCONSISTENT LO READINGS FROM HIS PRODIGY DIABETES METER. THE END USER WAS FEELING FATIGUED ACCOMPANIED WITH A BLOOD GLUCOSE READING OF LO. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 15MG/DL. THE END USER RECEIVED A TREATMENT TO ASSIST IN RAISING HIS BLOOD GLUCOSE BUT HE WAS NOT ABLE TO RECALL EXACTLY WHAT WAS GIVEN AND NOR WAS HE TRANSPORTED 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
    753162 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160819-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention CLONAZEPAM| LEVEMIR| LEVEMIR: 40 UNITS - AM| LEVEMIR: 40 UNITS - PM| LYRICA| METOCLOPRAMIDE| NOVOLOG| NOVOLOG: 23 UNITS - BREAKFAST| NOVOLOG: 23 UNITS - DINNER| NOVOLOG: 23 UNITS - LUNCH| POLYETHYLENE GLYCOL| SERTRALINE| TRAZODONE