BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8507413 · Received April 12, 2019

    Report

    Report Number
    3005862821-2019-00020
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 9, 2019
    Report Date
    March 15, 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
    AZ, 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 0.9¿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: D180616-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/58 MG/DL, FOR LEVEL HIGH WERE 290/292 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 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: D180616-1 ) WITH SUSPECTED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56/63 MG/DL; FOR LEVEL HIGH WERE 286/289 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 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 5PM DUE TO THE PRODIGY METER GIVING A RESULT OF 180MG/DL. END-USER STATED THAT THE 180MG/DL RESULT WAS NORMAL AND SHE TOOK HER INSULIN. END-USER STATED THAT SHE BEGAN GETTING SHAKY, SWEATY AND HAD TROUBLE BREATHING SO HER HUSBAND DROVE HER TO THE HOSPITAL. SHE DID NOT EAT OR DRINK ANYTHING PRIOR TO SEEKING MEDICAL ATTENTION. HER BLOOD GLUCOSE WAS 49MG/DL WHEN SHE ARRIVED AT THE HOSPITAL. SHE WAS GIVEN GLUCOSE BY MOUTH AND ORANGE JUICE TO BRING HER BLOOD GLUCOSE BACK UP. THE END-USER WAS NOT ADMITTED TO THE HOSPITAL SHE WAS THERE FOR 4 HOURS AND DISCHARGED. THE ER DOCTORS TESTED HER BLOOD GLUCOSE 2 TIMES AND THE RESULTS WERE 90MG/DL AND 120MG/DL. SHE STATED THAT SHE PERFORMED A CONTROL SOLUTION TEST THE WHEN SHE ARRIVED HOME AND HER METER GAVE A RESULT OF 37MG/DL. DISCHARGE INSTRUCTIONS WHERE TO MAKE SURE HER BLOOD GLUCOSE STAYS AROUND 120MG/DL. SHE WAS TREATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301069 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D180616-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization ASPRIN| DOFETILIDE| ESOMEPRAZOLE| FUROSEMIDE| GABAPENTIN| IRON| JANUVIA| MAGNESIUM| POTASSIUM| ROSUVASTATIN| VALSARTAN