BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6204333 · Received December 27, 2016

    Report

    Report Number
    3005862821-2016-00120
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE RETURNED METER, THE STANDBY CURRENT TEST WAS 1.0 A. THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE ALL OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/61 MG/DL, FOR LEVEL HIGH WERE 254/253 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    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 04/22/2013. 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2016-00120 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 12/27/2016 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT SHE SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 8:30AM AFTER RECEIVING CONTINOUS HIGH READINGS FROM THE PRODIGY DIABETES GLUCOSE METER WHICH CAUSE HER TO ADMINISTER TOO MUCH INSULIN. THE END USER STATED THAT SHE WAS DIZZY, DISORIENTED AND CONFUSED AND THE PARAMEDICS WERE CALLED. THE READING ON THE PRODIGY METER DURING THE TIME OF THE EVENT WAS 157 MG/DL. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AS WELL AS THE PRODIGY METER AND BOTH GAVE A RESULT OF 50 MG/DL. THE END USER WAS GIVEN ORANGE JUICE, PEANUT BUTTER AND JAM. END USER REFUSED TO GO TO THE ER AND HER BLOOD GLUCOSE PRIOR TO THE PARAMEDICS LEAVING WAS 77MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856229 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention ASPIRIN 81 MG ONCE A DAY| CARVEDILOL 12.5 MG TWICE A DAY| COQ10 300 MG ONCE A DAY| HUMALOG MIX 70/30 22 UNITS TWICE A DAY| HYDROCHLOROTHIAZIDE 25 MG (ON HOLD)| IMDUR 30 MG TWICE A DAY| LIPITOR 40 MG AT NIGHT| MULTIVITES AND VITAMIN D ONCE A DAY| NITROSTAT 150 MG AS NEEDED| NORVASC 5 MG (ON HOLD)| NOVOLOG REGULAR SLIDING SCALE AM/PM| PLAVIX 75 MG ONCE A DAY| RANEXA 500 MG 4X A DAY| SUCRALFATE 1 G TWICE A DAY| ZANTAC 150 MG TWICE A DAY