BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7668823 · Received July 8, 2018

    Report

    Report Number
    3005862821-2018-00035
    Event Type
    Injury
    Date Received
    July 8, 2018
    Date of Event
    June 16, 2018
    Report Date
    June 27, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OKB TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.0A. 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 RETURNED STRIPS (STRIP LOT NUMBER: D160720-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/60 MG/DL, FOR LEVEL HIGH WERE 249/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS(STRIP LOT NUMBER: D160720-1 ) WITH PATIENT'S RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/70 MG/DL; FOR LEVEL HIGH WERE 247/250 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 APPROXIMATELY AT 1130 DUE SYMPTOMS OF HYPOGLYCEMIA. A BLOOD GLUCOSE TEST WAS PERFORMED ON THE PRODIGY METER AND THE RESULT WAS 145 MG/DL. REPORTER IMMEDIATELY CONTACTED THE PARAMEDICS AFTER RECEIVING THE RESULT AS THE END-USER WAS "NOT HIMSELF" AND INCOHERENT. REPORTER STATED THE END-USER ATE BREAKFAST EARLIER AND DID NOT TAKE ANY MEDICATIONS PRIOR TO SEEKING MEDICAL ATTENTION. END-USER JUST LAID IN THE BED WHILE WAITING FOR THE PARAMEDICS TO ARRIVE AT HOME. PARAMEDICS ARRIVED WITHIN 5 MINUTES OF CALLING AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A 33 MG/DL. REPORTER STATED ABOUT 10 MINUTES WERE IN-BETWEEN TESTING THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS ADMINISTER A GLUCOSE GEL ORALLY AND TRANSPORTED END-USER TO THE HOSPITAL. REPORTER IS UNKNOWN OF THE BLOOD GLUCOSE RESULT UPON ARRIVAL AT THE HOSPITAL AND THE END-USER WAS GIVEN FOOD TO RAISE BLOOD GLUCOSE. END-USER HAD A CT SCAN TO RULE OUT STROKE, REPORTER STATED CT CAME BACK NORMAL. DURING INITIAL REPORT, END-USER WAS STILL IN THE HOSPITAL. END-USER IS STORING TESTING SUPPLIES IN THE BATHROOM. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510844 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160720-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R ALLOPURINOL| DIGOXIN| DONEPEZIL| FUROSEMIDE| HUMALOG, SLIDING SCALE 0-15 UNITS| LANTUS, UNKNOWN UNITS| SPIRONOLACTONE| XARELTO