BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6204364 · Received December 27, 2016

    Report

    Report Number
    3005862821-2016-00118
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 19, 2016
    Report Date
    November 19, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE RETURNED STRIPS WERE TESTED WITH OUR STANDARD SOLUTION, AND THE READINGS WERE ALL WITHIN THE RANGE. CHECK THE RETURNED METER, THE STANDBY CURRENT TEST WAS 0.9¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE ALL OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME STRIP LOT NUMBER AS PATIENT'S RETURNED STRIP, LOT# D160112-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/63 MG/DL, FOR LEVEL HIGH WERE 254/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. TESTED PATIENT'S RETURNED STRIPS (STRIP LOT NUMBER:D160112-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/64 MG/DL; FOR LEVEL HIGH WERE 268/267 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 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 (B)(4) ON 07/05/2013. THE STRIP LOT #D160112-2 WAS MANUFACTURED ON 01/12/2016 AND EXPIRED IN 01/2018. OKB TESTED THE RETAIN STRIPS(STRIP LOT NUMBER:D160112-2) WITH CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/63 MG/DL; FOR LEVEL HIGH WERE 254/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . OK BIOTECH RECEIVED NO OTHER COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. 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 3005862821-2016-00118 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 12/27//2016 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) 2016 BETWEEN 7:00 - 8:00 PM AFTER THE END USER WAS RECEIVING INCONSISTENT LOW READINGS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER CHECKED HIS BLOOD GLUCOSE SEVERAL TIMES AND CONTINUOUSLY RECEIVED LOW READINGS WHICH CAUSED CONCERN AND RESULTED IN A VISIT TO THE ER. THE END USER WAS NOT EXPERIENCING ANY UNUSUAL SYMPTOMS. UPON ARRIVAL TO THE ER THE END USERS BLOOD GLUCOSE WAS 123 MG/DL. NO TREATMENT WAS ADMINISTERED AND SEVERAL BLOOD GLUCOSE TEST WERE PERFORMED WITH THE HOSPITALS METER AND THE END-USERS PRODIGY METER. THE HOSPITAL METER READ 114 MG/DL AND THE PRODIGY METER RESULT WAS 123 MG/DL. UPON DISCHARGE THE END USER WAS INSTRUCTED TO FOLLOW-UP WITH THEIR PCP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856553 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160112-2

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention AMIODARONE 100MG| BUMETANIDE 1MG| COLACE DIURETIC AS NEEDED| ELIQUIS 2.5 TWICE A DAY| HYDRALAZINE 25MG TWICE A DAY| ISOSORBIDE MONONITRATE ER TABLETS 30MG| METOPROLOL SUCCINATE 50MG| NOVOLOG 70-30 UNITS| OMEPRAZOLE 1 A DAY| TRAMADOL HCL 50MG