BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8756814 · Received July 3, 2019

    Report

    Report Number
    3005862821-2019-00025
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 29, 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
    TX, 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 18.6¿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: D180619-1 ONLY (B)(4) PCS ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 148/127 MG/DL, FOR LEVEL HIGH WERE 354/353 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. DESICCANT COLOR INSIDE THE BOTTLE HAD CHANGED, STRIP WERE MOIST. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER: D180619-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/60 MG/DL; FOR LEVEL HIGH WERE 262/271 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 . ACCORDING TO ABOVE TESTS, WE FOUND THE METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS FROM PATIENT'S STRIP MIGHT BECAUSE PATIENT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:00PM. END-USER WAS AT HER DAUGHTER'S HOUSE (B)(6). CALLER REPORTED THAT THE PRODIGY METER GAVE A RESULT OF 541MG/DL SO SHE CALLED 911. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY WOULD BE AROUND 120-140MG/DL. PARAMEDICS WERE CALLED ABOUT A MINUTE AFTER TESTING WITH THE PRODIGY METER. PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED WITH THEIR METER AND RECEIVED A RESULT OF 142MG/DL. THERE WERE APPROXIMATELY 7 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. PARAMEDICS DID NOT TEST WITH THE PRODIGY METER. END-USER COMPLAINED OF A HEADACHE. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. PRIOR TO SEEKING MEDICAL ATTENTION, THE END-USER TOOK 8 UNITS OF LANTUS AND HIS DAILY DINNER MEDICATIONS (CALLER DID NOT KNOW WHAT MEDICATIONS THE END-USER TAKES. END-USER IS ON A SLIDING SCALE WHICH IS AS FOLLOWS NOVOLOG 3 TIMES A DAY ON A SLIDING SCALE. 80-120MG/DL 5 UNITS, 121-160MG/DL 6 UNITS, 161- 200MG/DL 7 UNITS, 201-240MG/DL 8 UNITS, 241-280MG/DL 9 UNITS, 281-320MG/DL 10 UNITS, 321-360MG/DL 11 UNITS, 361-400MG/DL 12 UNITS, 401-440MG/DL 13 UNITS, 441-580MG/DL 14 UNITS, 581MG/DL AND UP END-USER HAS TO SEEK MEDICAL ATTENTION. LANTUS NOT PROVIDED. END-USERS LANTUS WAS CHANGED AFTER SEEKING MEDICAL ATTENTION TO 10 UNITS EVERY NIGHT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552809 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D180619-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention LANTUS| NOVOLOG