BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8774945 · Received July 10, 2019

    Report

    Report Number
    3005862821-2019-00028
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 13, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OK BIOTECH 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 IN HOUSE STRIPS (STRIP LOT NUMBER: D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/62 MG/DL, FOR LEVEL HIGH WERE 261/256 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. PATIENT'S STRIPS LOT# D161007-2 WAS MANUFACTURED ON OCT. 07, 2016 AND EXPIRED IN OCT. 2018. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT THE END-USES HOME. THE END-USER STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST AROUND 10:00AM AND RECEIVED A RESULT THAT WAS 519MG/DL. A NORMAL BLOOD GLUCOSE READING FOR HER IS AROUND 120MG/DL. END -USER STATED SHE WASN'T FEELING WELL, AND SHE DROVE HERSELF TO (B)(6) HEALTH LOCATED AT (B)(6). END-USER STATED THAT SHE DOES NOT REMEMBER WHAT HER BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL JUST THAT IT WAS HIGHER THAN NORMAL . SHE STATED THAT SHE WAS GIVEN A TABLET TO LOWER HER BLOOD GLUCOSE. SHE WAS DISCHARGED AFTER 6 HOURS AND HER BLOOD GLUCOSE WAS AROUND 200MG/DL. METER MEMORY WAS DELETED SO THE END-USER WAS UNABLE TO PROVIDE TEST RESULTS. END-USER WAS INFORMED THAT HER TEST STRIPS ARE EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568266 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D161007-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization BENAZEPRIL| BUMETANIDE| FELODIPINE| FENOFIBRATE| LYRICA| NOVOLOG 70/30| OMEPRAZOLE