BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7127886 · Received December 19, 2017

    Report

    Report Number
    3005862821-2017-00135
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 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
    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 06/14/2013. THE STRIP LOT # D151019-1 WAS MANUFACTURED ON OCT. 2015 AND EXPIRED IN OCT. 2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . ACCORDING TO IMPORTER'S REPORT, PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AROUND 1:00 PM AFTER THE END USER ALLEGED SHE RECEIVED VARIOUS BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. IT WAS ALSO DISCOVERED THAT THE END USER WAS USING EXPIRED TEST STRIPS. THE END USER EXPERIENCED SHAKING AND BLURRY VISION ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 153 MG/DL. THE END USER WAS TAKEN TO URGENT CARE AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS AROUND 500 MG/DL. THE END USER STATED THAT NO TREATMENT WAS ADMINISTERED EVEN THOUGH HER BLOOD GLUCOSE WAS AROUND 500 MG/DL AND SHE WAS AT THE FACILITY FOR 2 HOURS. SHE WAS DISCHARGED WITH HER BLOOD GLUCOSE STILL HOVERING AROUND 500 MG/DL WITH NO FOLLOW-UP INSTRUCTIONS. THE END USER FOLLOWED UP WITH HER PCP AFTER THE MEDICAL EVENT AND HER METFORMIN WAS ADJUSTED FROM 500 MG TO 1000MG TWICE A DAY. NO ADDIITONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909449 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151019-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention HYDROCHLOROTHIAZIDE| METFORMIN| METOPROLOL TARTRATE