BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6176307 · Received December 15, 2016

    Report

    Report Number
    3005862821-2016-00112
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 04/30/2013. THE STRIP LOT #D150731-1 WAS MANUFACTURED ON 07/31/2015 AND EXPIRED IN 07/2017. 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

    END USER REPORTED THAT SHE SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 11:15 AM AFTER EXPERIENCING A HIGH READING FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER WENT TO THE ER AFTER FEELING DIZZY, LIGHT HEADED AND HUNGRY. SHE PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 560 MG/DL. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE WAS 272 MG/DL AND SHE RECEIVED AN IV TREATMENT TO LOWER HER LEVELS. NO FURTHER TREATMENT WAS PROVIDED. THE ER PHYSICIAN ADVISED THE END USER TO FOLLOW HER DOCTOR'S INSTRUCTIONS AND TAKE ONLY THE PRESCRIBED DOSAGE OF NOVOLOG. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829281 PRODIGY AUTOCODE B.LOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150731-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 5 UNITS OF NOVOLOG 10 MINTUTES BEFORE MEAL 3 TIMES| EFFEXOR| GABAPENTIN NOT TAKEN DAILY| LANTUS| NOVOLOG 30 UNITS IN AM AND 30 UNITS AT NIGHT