BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7340621 · Received March 15, 2018

    Report

    Report Number
    3005862821-2018-00022
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 5, 2018
    Report Date
    February 22, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 RETURN METER, THE RESULT WAS 1.2 A. THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170323-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/64 MG/DL, FOR LEVEL HIGH WERE 279/282 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER:D170323-1) WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/69 MG/DL; FOR LEVEL HIGH WERE 279/287 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 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) 2018 AT 11:00 PM AFTER IT WAS ALLEGED THAT THE END USER RECEIVED LOWER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER EXPERIENCED CONFUSION, GLOSSY LOOKING EYES, CLAMMY SKIN AND WAS ROCKING BACK AND FORTH ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 37 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 37 MG/DL. AN ADDITIONAL BLOOD GLUCOSE TEST WAS PERFORMED WITH THE PRODIGY METER AND THE READING WAS 87 MG/DL. THE END USER RECEIVED A GEL TREATMENT TO ASSIST IN RAISING HIS BLOOD GLUCOSE LEVEL AND THERE WAS NO FURTHER NEED FOR TRANSPORT TO THE ER. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185113 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D170323-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention ASPIRIN 81MG 3X A WEEK| ATORVASTATIN| DONEPEZIL| FOLIC ACID| FUROSEMIDE| HUMALOG 40 UNITS 2X A DAY| LANTUS 12 UNITS 1X A DAY| LEVOTHYROXINE| METOPROLOL| PANTOPRAZOLE| POTASSIUM| PROBENECID| TAMSULOSIN| VITAMIN B12| VITAMIN D