BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6921446 · Received October 6, 2017

    Report

    Report Number
    3005862821-2017-00097
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 7, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841753005
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OKB RECEIVED THE SUSPECTED METER FROM PDC, THE SERIAL NUMBER IS # (B)(4), AND THE SERIAL NUMBER IN THE INITIAL REPORT #3005862821-2017-00097 WAS INCORRECT. OKB INVESTIGATED AND CALCULATED THAT THE RETURNED METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTSED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 0.7A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. 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 59/59 MG/DL, FOR LEVEL HIGH ARE 248/237 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. 4. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, SO WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, STRIP LOT NUMBER:D170123-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/57 MG/DL; FOR LEVEL HIGH WERE 249/257 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 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)), SERIAL NUMBER WAS INCORRECT NUMBER AND WE CAN'T FIND THE MANUFACTURING RECORD FOR THE METER. THE STRIP LOT # D170123-1 WAS MANUFACTURED ON 01/23/2017 AND EXPIRED IN 01/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE REMAIN STRIPS OF #D170123-1 WITH OUR IN HOUSE METER AND CONTROL SOLUTION, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 51/46 MG/DL; FOR LEVEL HIGH WERE 232/238 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00097 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON OCT. 12,2017 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 HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH A RESULT OF 336 MG/DL. HE DID NOT EXPERIENCE ANY SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN HE WAS TAKEN TO THE ER AS A PRECAUTION. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE WAS 241 MG/DL. THE END USER STATED THAT NO TREATMENT WAS ADMINISTERED TO STABILIZE HIS BLOOD GLUCOSE LEVEL. BLOOD AND URINE TEST WERE PERFORMED AND THE RESULTS WERE NORMAL. AFTER 4 HOURS IN THE ER, THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 276 MG/DL AND HE WAS 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
    702099 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D170123-1 00384841753005

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention