BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6536061 · Received May 2, 2017

    Report

    Report Number
    3005862821-2017-00034
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 28, 2017
    Report Date
    March 28, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. THE STRIP LOT #D160802-1 WAS MANUFACTURED ON 08/02/2016 AND EXPIRED IN 08/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS LOT# D160802-1 IN OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/65 MG/DL; FOR LEVEL HIGH WERE 255/261 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.

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE RETURNED AND EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS: 1. WE TESTED THE STANDBY CURRENT OF THE RETURNED METER, THE TEST WAS 1.0¿A. THE CRITERIA IS <55¿A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. BECAUSE THE SUSPECTED STRIPS(LOT#: D160802-1) DID NOT RETURNED FROM PATIENT, 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 63/59 MG/DL, FOR LEVEL HIGH WERE 240/249 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 AROUND 11:00 PM AFTER RECEIVING A RESULT IN THE 500'S FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER WAS SWEATING AND SHAKING AND THE PARAMEDICS WERE CALLED. WHILE WAITING ON THE PARAMEDICS THE END USER DRANK SOME WATER AND ATE (B)(6) CRACKERS. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 198 MG/DL WHICH IS IN NORMAL RANGE. NO ADDITIONAL TREATMENT WAS ADMINISTERED. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00034 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 05/03//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318222 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160802-1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention ASPIRIN 81 MG ONCE A DAY| COREG ONCE A DAY| GLIPIZIDE 2.5 TWICE A DAY| LASIX 40 MG TWICE A DAY| PROTONIX 1 IN THE MORNING