BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8251948 · Received January 16, 2019

    Report

    Report Number
    3005862821-2019-00005
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 2, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.4A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER:D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/58 MG/DL, FOR LEVEL HIGH WERE 281/281 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. 4.ACCORDING TO PDC, PATIENT WAS USING STRIP LOT#D170524-1 FOR TESTING BLOOD. BUT PATIENT DID NOT RETURN HIS STRIPS. SO WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT STRIPS, LOT NUMBER:D170524-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/64 MG/DL; FOR LEVEL HIGH WERE 254/260 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

    THE REPORTER STATED THAT ON (B)(6) 2018 AT APPROXIMATELY 0300, MEDICAL ATTENTION WAS SOUGHT AFTER THE END USER RECEIVED A HIGH GLUCOSE TEST RESULT OF 404MG/DL WHEN USING THE PRODIGY METER. THE REPORTER STATED THAT HE WAS ASLEEP THRASHING AROUND WHEN HIS DOG WOKE UP HIS SON. HIS SON TRIED TO WAKE HIM UP BUT WAS UNABLE TO DO SO. HIS SON THEN CALLED THE EMTS AND PARAMEDICS ARRIVED IN APPROXIMATELY 40 MINUTES. PARAMEDICS TESTED THE ENDUSERS BLOOD GLUCOSE WHEN THEY ARRIVED AND RECEIVED A RESULT OF 37MG/DL. THERE WAS APPROXIMATELY 4 HOURS BETWEEN BLOOD GLUCOSE TESTING PERFORMED USING THE PRODIGY METER AND THE PARAMEDICS TEST RESULT. THE END USER WAS GIVEN A GLUCOSE INJECTION BY PARAMEDICS. THE PATIENT DECLINED TO GO TO THE HOSPITAL. PARAMEDICS TESTED THE END-USER BEFORE LEAVING AND RECEIVED A BLOOD GLUCOSE TEST RESULT IN THE MID 90S/MG/DL. THE END USER TESTED HIS BLOOD GLUCOSE AGAIN USING THE PRODIGY METER AND RECEIVED A RESULT OF 353MG/DL. NO OTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45423 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention AVODART 0.5MG| FLOMAX 0.4 MG| HUMALOG 17MG 3 TIMES A DAY| LANTUS 23MG AT NIGHT| LIPITOR 10MG| PANTOPRAZOLE 40MG| PROPRANOLOL 10MG| SPIRONOLACTONE 50MG