BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8330002 · Received February 11, 2019

    Report

    Report Number
    3005862821-2019-00009
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    December 18, 2018
    Report Date
    January 9, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    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. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2¿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: D171019-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/66 MG/DL, FOR LEVEL HIGH WERE 262/269 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP LOT NUMBER: D171019-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/58 MG/DL; FOR LEVEL HIGH WERE 250/249 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 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 AROUND 10:00AM. METER GAVE A RESULT OF 80MG/DL AND EMS WAS CALLED. REPORTER STATED THAT THE PRODIGY METER GAVE A READING OF 80MG/DL HOWEVER DUE TO THE END-USER BEHAVING ERRATICALLY EMS WERE CALLED AROUND 45 MINUTES AFTER TESTING. REPORTER STATED THAT AFTER TESTING HER BLOOD GLUCOSE HE GAVE HER SOME CANDY AND ORANGE JUICE, TESTED AGAIN AND GOT A 39MG/DL. EMS ARRIVED WITHIN 15 MINS TESTED HER AND RECEIVED A 31MG/DL. END-USER WAS NOT TRANSPORTED TO THE ER. EMS GAVE HER ORANGE JUICE AND NO OTHER TREATMENT. REPORTER DOESN'T RECALL WHAT HER BLOOD GLUCOSE WAS PRIOR TO THE EMS LEAVING. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118088 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 D171019-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention AMITRIPTYLINE 100MG| CLOPIDOGREL 75MG| DIAZEPAM 5MG| FUROSEMIDE 40MG| HUMULIN R U-500 18MG| LOSARTAN 25MG| SENNA 8.6MG| SIMVASTATIN 20MG| ZOLPIDEM 10MG