BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5491364 · Received March 10, 2016

    Report

    Report Number
    3005862821-2016-00010
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    January 23, 2016
    Report Date
    January 29, 2016
    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 AND RETURNED STRIPS EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS AND RETURNED STRIPS ARE AT THE SAME PERFORMANCE WITH OUR RETAINED STRIPS. ON DEVICE TESTING: THE STANDBY CURRENT TEST IS 1.5A. THE CRITERIA IS <55UA, PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAINED STRIPS, SAME STRIP LOT D150806-2 THAT PATIENT RETURNED. THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 60/61 MG/DL, FOR LEVEL HIGH ARE 281/278 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. WE ALSO TESTED THE RETURNED STRIPS FROM PATIENT (STRIP LOT NUMBER: D150806-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/64 MG/DL; FOR LEVEL HIGH WERE 276/271 MG/DL.ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS THE PERFORMANCE OF OUR RETAINED STRIPS AND PATIENT RETURNED STRIPS ARE ALL THE SAME. HENCE FIND NO FAILURE ON BOTH METER AND STRIPS. (B)(4).

    Description of Event or Problem · 1

    OUR IMPORTER, PRODIGY DIABETES CARE, RECEIVED A CALL ON (B)(6) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 11PM. PATIENT'S WIFE ((B)(6)) CALLED IN STATING THAT PATIENT BLOOD GLUCOSE TESTED HIGHER THAN NORMAL AND WAS UNABLE TO GET UP FROM A NAP. PATIENT WAS EXPERIENCING SYMPTOMS OF FATIGUE AND COULD NOT SPEAK CLEARLY. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 528MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE READING AT THE TIME OF DAY OF THE EVENT IS 130MG/DL. PARAMEDICS WERE CALLED 30 MINUTES AFTER TESTING WITH THE PRODIGY METER. PARAMEDICS ARRIVED 10-15 MINUTES AFTER BEING CALLED. APPROXIMATELY 30-45 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS TESTED PATIENT'S GLUCOSE WITH THEIR METER BUT ONLY STATED THAT THE RESULTS WERE LOW. PATIENT WAS TRANSPORTED TO ER BY PARAMEDICS. UPON ARRIVAL AT ER PATIENT'S BLOOD GLUCOSE WAS NOT REGISTERING BECAUSE IT WAS TOO LOW. PATIENT'S GLUCOSE UPON DISCHARGE WAS 130MG/DL. IT WAS UNKNOWN WHAT TREATMENT PATIENT RECEIVED AT ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148996 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150806-2

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention FLOMAX 0.4MG