BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6553384 · Received May 9, 2017

    Report

    Report Number
    3005862821-2017-00037
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 10, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED METER AND STRIPS WERE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF THE RETURNED METER, THE RESULT WAS 1.3¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE RETURNED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS FROM PATIENT (STRIP LOT NUMBER:D151125-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/68 MG/D, FOR LEVEL HIGH WERE 273/268 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. WE TESTED THE RETAIN STRIPS OF SAME LOT OF SUSPECT STRIP FROM PATIENT (LOT NUMBER: D151125-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/59 MG/DL; FOR LEVEL HIGH WERE 253/255 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 BETWEEN 10 - 11 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS DEHYDRATED, SWEATING, UNRESPONSIVE AND FELT LIKE HER BLOOD GLUCOSE HAD DROPPED TOO LOW. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A READING OF 35 MG/DL. THE END USER WAS GIVEN IV FLUIDS AND TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER, HER BLOOD GLUCOSE WAS 34 MG/DL. THE END USER WAS ADMITTED TO THE HOSPITAL AND ADDITIONAL IV FLUIDS WERE ADMINISTERED TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVELS. THE END USER REMAINED HOSPITALIZED FOR AN UNDISCLOSED AMOUNT OF TIME. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334921 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D151125-1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HUMALOG SLIDING SCALE 2 UNITS| LABETALOL| LANTUS 18 UNITS| LISINOPRIL| LYRICA 75MG| PROTONIX| SYNTHROID 50-100MG