BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7012487 · Received November 9, 2017

    Report

    Report Number
    3005862821-2017-00121
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 9, 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
    IN, 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 STANDBY CURRENT TEST OF RETURN METER, THE RESULT WAS 16.6 A, THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE 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 60/55 MG/DL, FOR LEVEL HIGH WERE 252/261 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. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. 1. 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 PDC ON 04/22/2013. 2. THE STRIP LOT # D150529-1 WAS MANUFACTURED ON 05/29/2015 AND EXPIRED IN MAY 29, 2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00121 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON JAN.16, 2018 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 6:00 PM AFTER THE END USER RECEIVED VARIED BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER WHEN COMPARING TO ANOTHER METER. THE END USER EXPERIENCED CONFUSION, BLURRED VISION AND SWEATING ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 183 MG/DL. FOUR ADDITIONAL BLOOD GLUCOSE TEST WERE PERFORMED WITH HIS PRODIGY METER WITH THE FOLLOWING RESULTS: 224MG/DL, 207MG/DL, 183 MG/DL AND 167 MG/DL. THE PARAMEDICS WERE CALLED AND ONCE THEY ARRIVED A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE READING WAS 71 MG/DL. THEY ALSO PERFORMED A BLOOD GLUCOSE TEST WITH THE PRODIGY METER AND THE READING WAS 136 MG/DL. THE END USER WAS NOT GIVEN ANY TREATMENT FROM THE PARAMEDICS AND WAS TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE READING WAS 150 MG/DL. NO TREATMENT WAS NECESSARY DUE TO HIS BLOOD GLUCOSE READING WAS WITHIN NORMAL RANGE. AFTER 2 HOURS IN THE ER THE END USER WAS DISCHARGED AND INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794411 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150529-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention AMLODIPINE BESYLATE| DUTASTERIDE| HUMULIN 20 UNITS PM| HUMULIN 35 UNITS AM| HYDROCHLOROTHIAZIDE| LOSARTAN| PRIMIDONE| TAMSULOSIN