BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6709790 · Received July 13, 2017

    Report

    Report Number
    3005862821-2017-00060
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 3, 2017
    Report Date
    June 9, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 08/25/2016. THE STRIP LOT # D160517-1 WAS MANUFACTURED ON 05/17/2016 AND EXPIRED IN 05/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF LOT# D160517-1. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/48 MG/DL; FOR LEVEL HIGH WERE 231/239 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. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT EARLY (B)(6) 2017 AFTER THE END USER'S PRODIGY DIABETES METER BECAME FROZEN ON THE LAST BLOOD GLUCOSE TEST AND WOULD NOT WORK PROPERLY. THE END USER FELT THAT HER BLOOD SUGAR WAS LOW AND ATTEMPTED TO PERFORM A BLOOD GLUCOSE TEST. SHE WAS NOT AWARE OF HER SURROUNDINGS AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER BUT THE END USER COULD NOT RECALL THE RESULT. NO TREATMENT WAS ADMINISTERED AND THE END USER WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER AN IV WAS ADMINISTERED AND AFTER SEVERAL DAYS IN THE HOSPITAL THE END USER WAS DISCHARGED. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490668 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160517-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention