BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8369305 · Received February 26, 2019

    Report

    Report Number
    3005862821-2019-00015
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 1, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 12/20/2016. THE STRIP LOT # D171011-1 WAS MANUFACTURED ON 10/11/2017 AND EXPIRED IN 10/11/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS, SAME AS PATIENT'S STRIPS# D171011-1 WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/63 MG/DL; FOR LEVEL HIGH WERE 239/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~75 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

    REPORTER ALLEGES THAT ON (B)(6) 2019 AT 5PM THE METER GAVE A RESULT OF HI AND MEDICAL ATTENTION WAS SOUGHT. REPORTER STATES THAT THE END-USER HAD A HEADACHE AND AFTER GETTING THE RESULT OF HI FROM THE PRODIGY METER SHE TOOK HIM TO ER. UPON ARRIVING AT THE ER THE END-USERS BLOOD GLUCOSE WAS 125MG/DL. REPORTERS STATED THAT THE END-USER WAS TREATED WITH A GLUCOSE SOLUTION ADMINISTERED BY IV. REPORTER STATED THAT HE DID NOT EAT OR DRINK ANYTHING PRIOR TO GOING TO THE ER. REPORTER STATED THAT THE ONLY ADDITIONAL TREATMENT RECEIVED WAS TO CHECK HIS BLOOD WORK AND THAT WAS NORMAL. HE WAS TREATED AND RELEASED AFTER 3 HOURS AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164197 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R ACTOPLUS MET| AMLODIPINE BESYLATE| COLCHICINE| FLUTICASONE PROPIONATE| FUROSEMIDE| GABAPENTIN| IPRATROPIUM BROMIDE| JANUVIA| LISINOPRIL| OLOPATADINE HYDROCHLORIDE| SPIRIVA| SYMBICORT