BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6342057 · Received February 18, 2017

    Report

    Report Number
    3005862821-2017-00017
    Event Type
    Injury
    Date Received
    February 18, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 13.1¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, 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 58/63 MG/DL, FOR LEVEL HIGH WERE 249/240 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) 2007 AT 3:00AM AFTER THE END USER WAS RECEIVING INCONSISTENT READINGS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER'S BLOOD GLUCOSE DURING THE MEDICAL EVENT WAS 110 MG/DL. THE END USER WAS INCOHERENT AND UNRESPONSIVE AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 39 MG/DL AND ADMINISTERED AN IV OF FLUID TO ASSIST WITH STABILIZING THEIR GLUCOSE LEVELS. NO FURTHER INFORMATION WAS PROVIDED IN RELATIONS TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124786 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ASPIRIN| BUMEX| COREG| DIGOXIN| IMBUR| LORATADINE| MAGNESIUM OXIDE| MYCOPHENOLATE| PRAZOSIN| PREDNISONE| PROBIOTIC| PROGRAF| SINGULAR| SYNTHROID| WARFARIN