BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7380637 · Received March 29, 2018

    Report

    Report Number
    3005862821-2018-00027
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 7, 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. OK BIOTECH TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.1¿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: D170426-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/59 MG/DL, FOR LEVEL HIGH WERE 233/242 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . .WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D170426-2 ) WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/58 MG/DL; FOR LEVEL HIGH WERE 249/252 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 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 8:30 PM AFTER THE END USER ALLEGED THAT HE HAS RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USERS SPEECH WAS SLURRED AND HE WAS INCOHERENT ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 100MG/DL. THE PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 40 MG/DL. AN ADDITIONAL BLOOD GLUCOSE TEST WAS PERFORMED WITH HIS PRODIGY METER AND THE RESULT WAS 71 MG/DL. THE PARAMEDICS ADMINISTERED TREATMENT TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE LEVEL, BUT THE END USER COULD NOT RECALL AS TO WHAT WAS GIVEN. THERE WAS NO REASONING 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
    224174 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D170426-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention DIALYSIS| HYDRALAZINE| METOPROLOL| NOVOLOG 30 - 70 UNITS| PLAVIX