BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6168736 · Received December 13, 2016

    Report

    Report Number
    3005862821-2016-00109
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 (B)(4) ON 04/28/2015. THE STRIP LOT #D151211-2 WAS MANUFACTURED ON 12/11/2015 AND EXPIRED IN 12/2017. OK BIOTECH RECEIVED NO OTHER COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. 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

    THE END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT IN (B)(6) 2016 BETWEEN 3AM TO 7AM DUE TO INCONSISTENT READINGS FROM THE PRODIGY DIABETES GLUCOSE METER. END USER STATED THAT SHE COULD NOT SLEEP AND PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A HI RESULT. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST BUT SHE COULD NOT RECALL THE EXACT READING AND BELIEVES IT WAS 20 MG/DL. SHE RECEIVED FLUIDS TO ASSIST IN RAISING HER GLUCOSE BUT COULD NOT REMEMBER EXACTLY WHAT WAS ADMINISTERED. THE END USER WAS TRANSPORTED TO THE ER AND ADMITTED TO THE HOSPITAL FOR OBSERVATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823402 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D151211-2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention AMLODIPINE| CARVEDILOL 12.5MG| GABAPENTIN 100MG TIMES 2| HYDRALAZINE| HYDROCODONE| LANTUS| METFORMIN 500MG