BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7284899 · Received February 21, 2018

    Report

    Report Number
    3005862821-2018-00011
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 20, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. OKB TESTED THE STANDBY CURRENT OF RETURN METER, THE RESULT WAS 0.7A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. 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 46/50 MG/DL, FOR LEVEL HIGH WERE 243/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. 4. WE RECEIVED THE SUSPECTED STRIPS FROM PATIENT, BUT THERE WERE ONLY 4 STRIPS IN THE VIAL AND THE REFERENCE # AND EXP. ARE RUBBED OFF. WE TESTED THE RETURNED STRIPS WITH OUR IN HOUSE CONTROL SOLUTION AND RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/59 MG/DL; FOR LEVEL HIGH WERE 254/256 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 AROUND 6:00 PM AFTER THE END USER ALLEGED THAT SHE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER WAS FOUND UNRESPONSIVE, HER FACE WAS RED AND SHE WAS COLD TO THE TOUCH ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 122 MG/DL. THE PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 21 MG/DL. THE PARAMEDICS ATTEMPTED TO ADMINISTER AN IV BUT FACED DIFFICULTIES AND THE END USER WAS TRANSPORTED TO THE ER. CONSEQUENT TO ARRIVING AT THE ER AN IV WAS DISPENSED TO ASSIST IN RAISING HER BLOOD GLUCOSE DUE TO EXPERIENCING HYPOGLYCEMIA INSULIN REACTION. AFTER 5 HOURS THE END USER WAS DISCHARGED AND INSTRUCTED TO RETURN TO THE ER IF HER CONDITION WORSENS. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128976 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ATORVASTATIN| B12| CYCLOBENZAPRINE| FOLIC ACID| LANTUS 40 UNITS PM| NOVOLOG 3 X DAILY 10 UNITS| TRAMADOL| VENTOLIN