BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7312420 · Received March 5, 2018

    Report

    Report Number
    3005862821-2018-00016
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    January 31, 2018
    Report Date
    January 31, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE WAS RETURNED AND EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURN 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 55/56 MG/DL, FOR LEVEL HIGH WERE 244/252 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. ACCORDING TO IMPORTER'S REPORT, PATIENT WAS STORING THE TEST STRIPS OUTSIDE OF THE ORIGINAL CONTAINER, AND STRIPS MIGHT GET MOISTURE BECAUSE OF IMPROPER STORAGE AND PRODUCE INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 12:00 PM AFTER THE END USER ALLEGED THAT SHE RECEIVED HIGHER THAN NORMAL READINGS FROM HER PRODIGY DIABETES METER. IT WAS ALSO DISCOVERED THAT THE END USER WAS STORING THE TEST STRIPS OUTSIDE OF THE ORIGINAL CONTAINER. SHE WAS EDUCATED ON THE PROPER STORAGE OF THE TEST STRIPS TO ELIMINATE ANY POSSIBLE TESTING ISSUES. THE END USER WAS SWEATING AND UNRESPONSIVE ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 191 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 31 MG/DL. THEY ALSO PERFORMED A BLOOD GLUCOSE TEST WITH THE PRODIGY METER AND THE READING WAS 321 MG/DL. GLUCOSE WAS GIVEN TO THE END USER TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL AND THERE WAS NO NEED FOR FURTHER 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
    155805 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention APRESOLINE 50MG 3X PER DAY| ASPIRIN 81MG DAILY| CALCITRIOL 0.25MCG DAILY| CEFTIN 250MG 2 X DAILY| COREG 12.5MG 2X A DAY| GABAPENTIN 100MG 3X A DAY| IMDUR 30MG DAILY| LAFIX 40MG DAILY| LEVEMIR 40 UNITS PM| LEVEMIR 60 UNITS DAYTIME| LEVOTHYROXINE SODIUM 75MCG DAILY| LIPITOR 20MG DAILY| NITROSTAT 0.4MG AS NEEDED| NORVASC 10MG DAILY| NOVALOG 20MG DAILY| OMEPRAZALE 20MG DAILY| POTASSIUM CHLORIDE 15ML DAILY| SERROUS SULFATE 325MG DAILY| SODIUM BICARBONATE 1300MG 3X A DAY