BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6039087 · Received October 19, 2016

    Report

    Report Number
    3005862821-2016-00086
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 11/06/2015. THE STRIP LOT #D160202-1 WAS MANUFACTURED ON 02/02/2016 AND EXPIRED IN 02/2018. 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

    (B)(4) RECEIVED A CALL ON 09/13/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 1:30PM. PATIENT ((B)(6)) CALLED IN STATING THAT THE PRODIGY METER WAS READING "LO" AFTER EACH READING FOR THE LAST 5 DAYS. (B)(6) WAS EXPERIENCING SYMPTOMS OF SWEATING AND DIZZINESS. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS "LO". (B)(6) NORMAL GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 125MG/DL. (B)(6) DRANK ORANGE JUICE PRIOR TO THE EVENT. (B)(6) HUSBAND DROVE HER TO THE HOSPITAL. UPON ARRIVAL AT THE ER, (B)(6) BLOOD GLUCOSE WAS 600MG/DL AND SHE WAS ADMITTED TO THE HOSPITAL. (B)(6) WAS GIVEN AN INSULIN IV DRIP WHILE AT THE HOSPITAL. (B)(6) BLOOD GLUCOSE PRIOR TO DISCHARGE WAS 181MG/DL. (B)(6) TOTAL STAY IN THE HOSPITAL WAS 7 HOURS. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693747 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160202-1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention INSULIN 6 UNITS