BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6766345 · Received August 4, 2017

    Report

    Report Number
    3005862821-2017-00073
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    June 24, 2017
    Report Date
    June 28, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 1.3¿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 IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/60 MG/DL, FOR LEVEL HIGH WERE 255/255 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. BECAUSE PATIENT DID NOT SEND BACK HIS STRIPS, SO WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME STRIP LOT AS PATIENT'S STRIPS, LOT#D160815-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/60 MG/DL; FOR LEVEL HIGH WERE 262/251 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT AFTER THE END USER WAS RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER COULD NOT SPEAK AND WAS NOT ABLE TO GET OUT OF THE BED. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 57 MG/DL. A BLOOD GLUCOSE TEST WAS ALSO PERFORMED WITH THE PRODIGY METER AND THE RESULT WAS 383 MG/DL. NO TREATMENT WAS ADMINISTERED BY THE PARAMEDICS AND THE END USER WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER THE END USER RECEIVED MILK, TOAST, CEREAL AND ORANGE JUICE TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE LEVEL. AFTER A FEW HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 157 MG/DL. HE WAS INSTRUCTED TO FOLLOW-UP WITH HIS PCP. AFTER FOLLOWING UP WITH HIS PCP THE END USER'S INSULIN WAS DECREASED FROM 25 TO 10 UNITS A DAY. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548009 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160815-1

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention FLOMAX| HYDROCODONE| INSULIN-NOVOLIN