BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8626680 · Received May 21, 2019

    Report

    Report Number
    3005862821-2019-00024
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 3, 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
    FL, 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 1.0¿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: D180116-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/56 MG/DL, FOR LEVEL HIGH WERE 242/252 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 WE TESTED THE RETAIN STRIPS (SAME AS PATIENT'S STRIP, LOT NUMBER: D180116-1) WITH SUSPECTED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/63 MG/DL; FOR LEVEL HIGH WERE 246/255 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) 2019 AT 7AM DUE TO THE END-USER BEING UNRESPONSIVE AFTER GETTING A NORMAL RESULT ON HIS PRODIGY METER. END-USER STATED HE RECEIVED A READING OF 114MG/DL ON HIS PRODIGY METER. HE STATED THAT HIS WIFE CALLED EMS WHEN HE BECAME DISORIENTED AND UNRESPONSIVE. END-USER IS UNSURE OF HOW LONG THE EMS TOOK TO ARRIVE. UPON ARRIVAL THE EMS TESTED HIS BLOOD GLUCOSE WITH THEIR METER AND GOT A RESULT OF 40MG/DL. THE EMS ADMINISTERED GLUCOSE IV TO THE END-USER TO BRING HIS BLOOD GLUCOSE BACK UP. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. HE STATED THAT HE HAS USED HIS PRODIGY METER FOR 2 YEARS AND TESTS HIS BLOOD GLUCOSE 3 TIMES DAILY. HIS NORMAL RANGE FOR THAT TIME OF DAY IS 90-100MG/DL NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420907 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 52800 D180116-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention CARBIDOPA / LEVODOPA| CLOPIDOGREL| FUROSEMIDE| HUMULIN N 25 UNITS 2X DAILY| ISOSORBIDE| ROSUVASTATIN