BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7298583 · Received February 27, 2018

    Report

    Report Number
    3005862821-2018-00013
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 29, 2018
    Report Date
    January 30, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. OKB TESTED THE STANDBY CURRENT OF RETURN METER, THE RESULT WAS 1.5¿A. THE CRITERIA IS <55¿A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. OKB 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 49/51 MG/DL, FOR LEVEL HIGH WERE 260/248 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. ACCORDING TO IMPORTER'S REPORT, PATIENT WAS USING INCOMPATIBLE TEST STRIPS WITH HIS PRODIGY METER (OTHER BRAND STRIPS), WHICH CONTRIBUTED TO THE ERROR CODES FROM THE PRODIGY METER.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2018-00013 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON FEB. 26, 2018 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    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 (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON DEC.02, 2016. ACCORDING TO IMPORTER'S REPORT, PATIENT WAS USING INCOMPATIBLE TEST STRIPS WITH HIS PRODIGY METER (OTHER BRAND STRIPS), WHICH CONTRIBUTED TO THE ERROR CODES FROM THE PRODIGY METER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AROUND 10:00 PM AFTER RECEIVING CONTINOUS L-B ERROR CODES FROM HER PRODIGY DIABETES METER. IT WAS ALSO DISCOVERED THAT THE END USER WAS USING INCOMPATIBLE TEST STRIPS (PHARMACISTS CHOICE TS). THE END USER WAS EDUCATED ON USING ONLY COMPATIBLE TEST STRIPS WITH THEIR METER. THE END USER WAS SHAKING, SWEATING, CONFUSED, LEG WEAKNESS AND HER HEART WAS POUNDING. SHE WAS TAKEN TO THE ER AND UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE HOSPITALS METER WITH A RESULT OF 18 MG/DL. AN IV OF GLUCOSE WAS ADMINISTERED TO ASSIST IN STABILIZING HER GLUCOSE RESULT. AFTER 4 HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 200 MG/DL. SHE WAS ALSO INSTRUCTED TO CONTINUE TO CHECK HER BLOOD GLUCOSE AND EAT SMALL SNACKS. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142588 PRODIGY AUTOCODE BLOOD GLUCSOE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ALLOPURINOL , 100MG ONCE A DAY| ASPIRIN , 81MG ONCE A DAY| ESCITALOPRAM, 20MG ONCE A DAY| GABAPENTIN , 300MG TWICE A DAY| ISOSORBIDE ,10MG TWICE A DAY| LASIX, 40MG| LEVOTHYROXINE 25MG ONCE A DAY| LISINOPRIL , 10MG TWICE A DAY| METOPROLOL , 25MG ONCE A DAY| NOVOLIN 45U 1X DAILY| PROTOCOL , 40MG ONCE A DAY| VITAMIN D 1500 UNITS 1X WEEK| ALLOPURINOL , 100MG ONCE A DAY| ASPIRIN , 81MG ONCE A DAY| ESCITALOPRAM, 20MG ONCE A DAY| GABAPENTIN , 300MG TWICE A DAY| ISOSORBIDE ,10MG TWICE A DAY| LASIX, 40MG| LEVOTHYROXINE 25MG ONCE A DAY| LISINOPRIL , 10MG TWICE A DAY| METOPROLOL , 25MG ONCE A DAY| NOVOLIN 45U 1X DAILY| PROTOCOL , 40MG ONCE A DAY| VITAMIN D 1500 UNITS 1X WEEK