BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY POCKET

    MDR report key: 6078322 · Received November 4, 2016

    Report

    Report Number
    3005862821-2016-00097
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 12.9UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 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 ARE 61/60 MG/DL; FOR LEVEL HIGH ARE 241/242 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

    THE END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 5:00PM AFTER RECEIVING HIGH READINGS FROM HIS PRODIGY DIABETES METER. THE END USER STATED HE FELT SHAKY AND COULD NOT STAND AND THE METER READ 201 MG/DL BUT HE QUESTIONED THE ACCURACY BASED UPON THE WAY HE WAS FEELING. THE PARAMEDICS WERE CALLED AND THEY PERFORMED A TEST WITH THEIR METER AND THE RESULT WAS 492 MG/DL HE RECEIVED AN IV OF FLUID TO LOWER HIS BLOOD SUGAR AND WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE WAS 388 MG/DL WHERE HE REMAINED ON THE IV DRIP. ADDITIONAL TEST WERE PERFORMED UNRELATED TO HIS DIABETES. THE END USER WAS HOSPITALIZED FOR 2 DAYS AND INSTRUCTED TO FOLLOW UP WITH HIS PCP. HIS BLOOD GLUCOSE AT DISCHARGE WAS 169 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730535 PRODIGY POCKET BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ALLOPURINOL| ASPIRIN| CARVEDILOL| DEPAKOTE ER| FLOMAX| ISOSORBIDE| LASIX| LYRICA| NOVOLIN 70/30| NOVOLIN R| PLAVIX| PROTONIX| RANEXA| SEROQUEL| SIMVASTATIN| VISTARIL