BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7147184 · Received December 27, 2017

    Report

    Report Number
    3005862821-2017-00142
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 26, 2017
    Report Date
    November 26, 2010
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RETURNED METER, THE RESULT WAS 1.1A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 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 52/60 MG/DL, FOR LEVEL HIGH WERE 241/239 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. BECASUE PATIENT DID NOT SEND BACK HIS STRIPS, SO WE TESTED THE TETAIN STRIPS TEST FROM OUR WAREHOUSE( SAME AS PATIENT'S STRIP, LOT NUMBER:D170119-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/54 MG/DL; FOR LEVEL HIGH WERE 262/259 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 .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 2:58 AM AFTER THE END USER ALLEGED THAT HE WAS RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED SEVERAL BLOOD GLUCOSE TESTS AND RECEIVED THE FOLLOWING RESULTS - 356 MG/DL AND 473 MG/DL. THERE WERE NO SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR THE HIGH READINGS THE PARAMEDICS WERE CALLED. UPON ARRIVAL THEY PERFORMED TWO BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULTS WERE 221 MG/DL AND 178 MG/DL. NO TREATMENT WAS ADMINISTERED AND THERE WAS NO NEED FOR TRANSPORT TO THE ER DUE TO THE FACT THAT THE END USER'S READINGS WERE WITHIN NORMAL RANGE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926584 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 73200 - D170119-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ASPRIN| BENZONATATE| CAPOTEN| FAMOTIDINE| HYDROXYZINE| LEVOTHYROXINE| LOSARTAN| LOVASTATIN| METOPROLOL| OMEPRAZOLE| PRIMIDONE| TEMAZEPAM| TYLENOL