BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7340618 · Received March 15, 2018

    Report

    Report Number
    3005862821-2018-00024
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 18, 2018
    Report Date
    February 28, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841503020
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 OF RETURNED METER, THE RESULT WAS 7.5UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170323-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/56 MG/DL, FOR LEVEL HIGH WERE 231/238 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER:D170323-1 ) WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/62 MG/DL; FOR LEVEL HIGH WERE 250/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 BETWEEN 9:00 - 10:00 PM AFTER THE END USER ALLEGED THAT SHE RECEIVED LOWER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER EXPERIENCED SWEATING, SHAKING AND FELT AS IF SHE WAS HAVING A SEIZURE ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 31 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL A BLOOD GLUCOSE TEST IS PERFORMED WITH THEIR METER AND THE RESULT WAS 37 MG/DL. AN ADDITIONAL BLOOD GLUCOSE TEST WAS PERFORMED WITH HER PRODIGY DIABETES METER BUT THE END USER COULD NOT RECALL THE RESULT. GLUCOSE WAS ADMINISTERED TO ASSIST IN RAISING HER BLOOD GLUCOSE LEVEL AND SHE WAS SUBSEQUENTLY TRANSPORTED TO THE ER. AFTER ARRIVING TO THE ER THE END USER WAS GIVEN IV FLUIDS AND ADMITTED TO THE HOSPITAL FOR 4 DAYS. THE END USER STATED THAT SHE RECEIVED ANTIBIOTICS BUT DID NOT DISCLOSE THE REASON FOR THE TREATMENT AND WAS DISCHARGED WITH INSTRUCTIONS TO PURCHASE A NEW GLUCOSE METER. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184814 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. N/A 52800 - D170323-1 00384841503020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R LEVEMIR 40 UNITS