BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6603960 · Received June 1, 2017

    Report

    Report Number
    3005862821-2017-00045
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    April 28, 2017
    Report Date
    May 2, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HOME HEALTH AIDE

    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 TEST 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 37/37 MG/DL, FOR LEVEL HIGH WERE 235/241 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 RETURN HER STRIPS, WE TESTED THE RETAIN STRIPS (LOT NUMBER: D160315-1) FROM OUR WAREHOUSE WITH HER RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/61 MG/DL; FOR LEVEL HIGH WERE 258/267 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 BETWEEN 5:30 - 6:00 PM AFTER HER PRODIGY DIABETES METER WAS DROPPED AND SHE WAS RECEIVING INCONSISTENT RESULTS. THE PARAMEDICS WERE CALLED DUE TO THE END USER BECOMING NERVOUS AND NOT SURE HOW MUCH INSULIN SHE SHOULD TAKE BECAUSE OF THE INCONSISTENT BLOOD GLUCOSE READINGS. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER BUT SHE COULD NOT RECALL THE RESULT. THERE WAS NO TREATMENT PROVIDED BY THE PARAMEDICS AND SHE WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE WAS 169 MG/DL. NO TREATMENTS WERE PROVIDED WHILE AT THE ER AND AFTER 4 - 5 HOURS THE END USER WAS DISCHARGED AND INSTRUCTED TO OBTAIN A NEW GLUCOSE METER. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386175 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D160315-1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention BAYER ASPRIN| CLOPIDOGREL 75 MG/DL| DOK (STOOL SOFTENER) 100 MG/DL| ISOSORBIDE MONONITRATE| LANTUS 26 UNITS ONCE A DAY| LEVOTHYROXINE| LISINOPRIL 20MG/DL| NAMZARIC 28 MG/DL| NOVOLOG 3 TIMES A DAY SLIDING SCALE| OPTHALMIC SOLUTION 5% (EYE DROPS)| PANTOPRAZOLE ZOLE 40 MG/DL| PREDNISOLONE| SIMVASTATIN 10 MG/DL| TILOMAN MIL (EYE DROPS)| TRAVATAN (EYE DROPS)| VITAMIN D 50000 MG/DL