BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9206458 · Received October 18, 2019

    Report

    Report Number
    3005862821-2019-00052
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 11, 2019
    Report Date
    September 19, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DID NOT RETURN HIS METER, BUT ONLY HIS STRIPS. 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 07/05/2017. WE TESTED THE RETURNED STRIPS (STRIP LOT NUMBER: D190107-2 ) WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/69 MG/DL, FOR LEVEL HIGH WERE 231/227 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS OF SAME BATCH (STRIP LOT NUMBER: D190107-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/61 MG/DL; FOR LEVEL HIGH WERE 222/217 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 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

    REPORTER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 2:15PM AT THE END-USER'S HOME. REPORTER STATED THE END-USER TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 109MG/DL. REPORTER SAID THAT HE TESTED AGAIN AND RECEIVED A RESULT OF 142MG/DL. REPORTER STATED THAT THE END-USER ATE A HAMBURGER AND BEANS AND TOOK 8 UNITS OF NOVOLOG PRIOR TO SEEKING MEDICAL ATTENTION. APPROXIMATELY 3 HOURS AFTER TESTING WITH HIS PRODIGY METER THE END-USER STARTED FEELING DISORIENTATED AND SLUR HIS SPEECH REPORTER STATED THAT THE EMS WERE CALLED. REPORTER STATED THAT THE END-USER DRANK APPLE JUICE WHILE WAITING FOR PARAMEDICS WHO ARRIVED WITHIN 5 MINUTES. THE PARAMEDICS TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 32MG/DL, THEY DID NOT TEST WITH HIS PRODIGY METER. PARAMEDICS HAD THE END-USER DRINK A COCA COLA TO RAISE HIS BLOOD GLUCOSE. HE WAS NOT TRANSPORTED TO THE HOSPITAL. PRIOR TO THE PARAMEDICS LEAVING HIS BLOOD GLUCOSE WAS 60MG/DL, AND THEY ADVISED THE END-USER TO EAT. THE END-USER IS PRESCRIBED INSULIN ON THE FOLLOWING SLIDING SCALE: NOVOLOG: 8 UNITS BEFORE EACH MEAL. ADD 1 UNIT FOR EVERY 3 POINTS HIGHER FROM 150 MG/DL. LEVEMIR: 25 UNITS AT BEDTIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002113 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190107-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention