BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6860932 · Received September 13, 2017

    Report

    Report Number
    3005862821-2017-00091
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 3, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT TEST OF RETURNED METER, THE RESULT WAS 1.0¿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:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/51 MG/DL, FOR LEVEL HIGH WERE 243/248 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 12:00 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED SEVERAL BLOOD GLUCOSE TESTS WITH THE FOLLOWING RESULTS - 580 MG/DL AND 450 MG/DL. SHE WAS NOT EXPERIENCING ANY SIGNIFICANT SYMPTOMS BUT CALLED THE PARAMEDICS OUT OF CONCERN WITH THE HIGH READINGS. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 108 MG/DL. NO TREATMENT WAS ADMINISTERED AND SHE WAS TRANSPORTED TO THE ER. AFTER 5 HOURS IN THE ER THE END USER WAS DISCHARGED. THERE WERE NO TREATMENTS GIVEN AND NO ADDITIONAL TESTS WERE PERFORMED. THE END USER WAS INSTRUCTED TO FOLLOW-UP WITH A DIABETIC CLINIC. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642094 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention AMLODIPINE 10 MG 1 TAB DAILY| ASPIRIN 81 MG ONCE A DAY| CARVEDILOL 625 MG ONCE PM| GABAPENTIN 600 MG ONE PM| LORATADINE 10 MG DAILY| LORATIN-10 MG ONCE DAILY| LOSARTAN 50 MG DAILY| MECLIZINE 25 MG ONE 3 X A DAY| MULTIVITAMIN 1 DAILY| SINGULAIR 10 MG ONCE| ZETIA 10 MG 1 DAILY