BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6953836 · Received October 16, 2017

    Report

    Report Number
    3005862821-2017-00103
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 17, 2017
    Report Date
    September 20, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 12/24/2015. THE STRIP LOT # D170106-1 WAS MANUFACTURED ON 01/06/2017 AND EXPIRED IN 01/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS(SAME AS PATIENT'S STRIP LOT NUMBER D170106-1) WITH OUR IN-HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56/58 MG/DL; FOR LEVEL HIGH WERE 237/229 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 190~300 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

    ON (B)(6) 2017 (B)(4) RECEIVED A CALL REPORTING A MEDICAL INTERVENTION THAT OCCURED ON (B)(6) 2017 AT 10:00AM. PATIENT'S (B)(6) DAUGHTER (B)(6) CALLED IN STATING THAT (B)(6) WAS RECEIVING HIGH BLOOD GLUCOSE TEST RESULTS. THE READING ON THE PRODIGY METER AT THE TIME OF THIS EVENT WAS 143MG/DL. (B)(6) WAS EXPERIENCING SYMPTOMS OF SLURRED SPEECH, AND WAS NOT COMPREHENDING WHEN SPOKEN TO. ONE ADDITIONAL TEST WAS PERFORMED ON THE PRODIGY METER WITH A RESULT OF AROUND 200MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AND ARRIVED 10 MINUTES LATER. (B)(6) WAS SEATED AND GIVEN KOOL AIDE WHILE WAITING ON PARAMEDICS TO ARRIVE. PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER BUT (B)(6) DID NOT REMEMBER THE RESULTS. (B)(6) NORMAL BLOOD GLUCOSE LEVEL AROUND THE TIME OF DAY OF THE EVENT IS 100MG/DL. (B)(6) STATED THAT (B)(6) WAS NOT TRANSPORTED THE ER BECAUSE BY THE TIME THE PARAMEDICS ARRIVED SHE WAS OK. (B)(4) SENT REPLACEMENT SYSTEM AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733049 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170106-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention GLIPERIDE 4MG TWICE A DAY| NOVALOG 30-70MG/DL TWICE A DAY