BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8507414 · Received April 12, 2019

    Report

    Report Number
    3005862821-2019-00021
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 16, 2019
    Report Date
    March 26, 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
    NY, 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 IN HOUSE STRIPS (STRIP LOT NUMBER: D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/56 MG/DL, FOR LEVEL HIGH WERE 259/259 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. PATIENT'S STRIP LOT#D150120-2 WAS MANUFACTURED ON JAN 20, 2015 AND EXPIRED IN JAN 2017. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED IR CONTRIBUTED TO ERROR READINGS. USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END-USER SOUGHT MEDICAL ATTENTION AROUND 11AM ON (B)(6) 2019 DUE TO THE METER GIVING A HIGHER READING THAN THE END-USER'S ACTUAL BLOOD SUGAR. END-USER STATED THEY RECEIVED A RESULT OF 167MG/DL ON HER PRODIGY METER. END-USER STATED SHE WAS NOT FEELING WELL AND FELL. END USER THEN CALLED HER DAUGHTER WHO CAME AND TOOK HER TO THE EMERGENCY ROOM WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 32MG/DL. END-USER WAS TREATED WITH A GLUCOSE IV FLUID. END-USER STATED SHE WAS ADMITTED TO THE HOSPITAL AND RELEASED THE NEXT DAY AROUND 5 PM. END-USER WAS USING EXPIRED TEST STRIPS. PRIOR TO SEEKING MEDICAL ATTENTION THE END-USER ATE TOAST, BANANA, AND COFFEE AND ALSO TOOK HER SYNTHROID MEDICATION. END-USERS DISCHARGE INSTRUCTIONS WERE TO FOLLOW UP WITH HER PRIMARY DR. WHO CHANGED HER LEVEMIR TO 36 UNITS IN THE MORNING AND AT NIGHT. END-USER WAS TREATED AT (B)(6) MEDICAL CENTER LOCATED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301079 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150120-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization BABY ASPIRIN| CRESTOR| LEVEMIR - 60UNITS IN THE MORNING, 50UNITS AT NIGHT| METFORMIN| METOPROLOL| SYNTHROID