BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6685479 · Received July 4, 2017

    Report

    Report Number
    3005862821-2017-00059
    Event Type
    Injury
    Date Received
    July 4, 2017
    Date of Event
    June 4, 2017
    Report Date
    June 5, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 1.8A. 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 IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/62 MG/DL, FOR LEVEL HIGH WERE 254/264 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. ACCORDING TO REPORTER'S DESCRIBE,THE SUSPECTED STRIP LOT #D130111-2, WHICH WAS MANUFACTURED ON 01/11/2013 AND EXPIRED ON 01/11/2015. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    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 # 51850-0939541), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 04/30/2013. ACCORDING TO REPORTER'S DESCRIBE,THE SUSPECTED STRIP LOT #D130111-2, WHICH WAS MANUFACTURED ON 01/11/2013 AND EXPIRED ON 01/11/2015. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00059 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 8:30 AM AFTER RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH A RESULT OF 290 MG/DL AND WENT TO THE ER. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE WAS 132 MG/DL. NO TREATMENT WAS ADMINISTERED DUE TO HER BLOOD GLUCOSE READING WAS WITHIN THE NORMAL RANGE AND DID NOT WARRANT ANY FURTHER ACTIONS. AFTER 20 MINUTES THE END USER WAS DISCHARGED FROM THE ER. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465925 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D130111-2

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention JANUVIA, 1 PILL A DAY,| LISINOPRIL 1 PILL A DAY,| SIMVASTATIN 1 PILL A DAY