BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6204337 · Received December 27, 2016

    Report

    Report Number
    3005862821-2016-00122
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 RETURNED METER, THE STANDBY CURRENT TEST WAS 0.8UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE ALL OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (LOT #D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/54 MG/DL, FOR LEVEL HIGH WERE 232/236 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 #D121210-1, WHICH WAS MANUFACTURED ON 12/10/2012 AND ALREADY EXPIRED ON 12/10/2014. 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 # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(5) ON 11/24/2015. ACCORDING TO REPORTER'S DESCRIBE,THE SUSPECTED STRIP LOT #D121210-1, WHICH WAS MANUFACTURED ON 12/10/2012 AND EXPIRED ON 12/10/2014. 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 3005862821-2016-00122 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) CARE ON 12/27/2016 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 10:45AM AFTER RECEIVING INCONSISTENT BLOOD GLUCOSE RESULTS FROM THE PRODIGY DIABETES METER. THE END USER DID NOT HAVE ANY SYMPTOMS BUT VISITED THE ER AFTER BECOMING CONCERNED WITH HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS. THE READING ON THE PRODIGY METER AT THE TIME OF THE MEDICAL EVENT WAS 282 MG/DL. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE DWINDLED DOWN TO 75MG/DL AND NO TREATMENT WAS ADMINISTERED. NO DISCHARGE INSTRUCTIONS WERE GIVEN AND THERE WERE NO RECENT MEDICATION CHANGES. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856027 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D121210-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LISINOPRIL 25MG 1 PILL DAILY| METFORMIN 500MG 1 PILL DAILY