BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5811511 · Received July 21, 2016

    Report

    Report Number
    3005862821-2016-00039
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    May 16, 2016
    Report Date
    June 7, 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 AT THAT TIME. THE STRIP LOT #D151113-1 WAS MANUFACTURED ON NOV. 13, 2015. WE DID NOT RECEIVE ANY SMILIAR COMPLAINTS FOR THIS BATCH OF STRIPS. BECAUSE 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

    OUR IMPORTER, (B)(4), RECEIVED A CALL ON 05/23/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 BETWEEN 9:00AM-10:00AM. PATIENT CALLED IN STATING THAT HE STARTED SHOWING SYMPTOMS OF PANTING, SWEATING, SHAKING, AND FEELING WEAK. PATIENT DID NOT CONSUME ANY FOOD BUT ONLY DRANK WATER UP UNTIL THE MEDICAL INTERVENTION. PATIENT STATED THAT THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS IN THE 200S(MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 66MG/DL. PARAMEDICS WERE CALLED AND ARRIVED AT PATIENT'S HOME WITHIN 45 MINUTES. PARAMEDICS PERFORMED A BLOOD GLUCOSE READING ON THE PATIENT WITH THEIR METER BUT PATIENT DID NOT REMEMBER THE ACTUAL RESULTS BUT THAT IS WAS VERY LOW. RESULTS. PATIENT ATE A (B)(6) TO RAISE HIS BLOOD GLUCOSE LEVEL. PATIENT REFUSED TO BE TRANSPORTED TO ER BY PARAMEDICS. (B)(64 SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466608 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151113-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention INSULIN 30 UNITS X1