BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9517511 · Received December 25, 2019

    Report

    Report Number
    3005862821-2019-00072
    Event Type
    Injury
    Date Received
    December 25, 2019
    Date of Event
    November 17, 2019
    Report Date
    November 25, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PDC ON 08/13/2018. THE STRIP LOT # D190104-1 WAS MANUFACTURED ON 01/04/2019 AND EXPIRED IN 01/04/2021. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. RETAIN STRIPS TEST. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/67 MG/DL; FOR LEVEL HIGH WERE 241/239 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 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

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 9:00PM AT HOME. END-USER STATED THAT ABOUT 5 HOURS AFTER GETTING AN 83MG/DL ON HIS PRODIGY METER HE WAS FOUND BY HIS MOTHER WHO WAS UNABLE TO WAKE HIM. END-USER STATED THAT HE TESTS HIS BLOOD SUGAR 3 TIMES A DAY AND A NORMAL RESULT FOR HIM IS AROUND 88MG/DL. HE IS ON A SLIDING WITH HIS NOVO LOG AND NOVOLIN AND IT IS AS FOLLOWS NOVOLIN: 5 UNITS IN THE MORNING AND 5 UNITS AT NIGHT. NOVOLOG SLIDING SCALE: 0-50MG/DL 1 UNIT 51-190MG/DL 2 UNITS, 191-261MG/DL 3 UNITS, 262-332MG/DL 4 UNITS, 333-403MG/DL 5 UNITS, 404- 474MG/DL 6 UNITS, 475-545MG/DL 7 UNITS, 546-616MG/DL 8 UNITS. HE STATED THAT HE DID NOT TAKE ANY MEDICATION OR CONSUME ANY FOOD WHILE WAITING FOR THE EMS. HE STATED THAT HE HAD EATEN DINNER THAT CONSISTED OF TENDERLOIN, HAMBURGER, HOT DOG, WATER AND DIET LEMONADE. HIS MOTHER CALLED EMS AND IT TOOK THEM ABOUT 15 MINUTES TO ARRIVE. EMS TESTED HIS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 24MG/DL. HE WAS THEN TRANSPORTED TO (B)(6) HEALTHCARE LOCATED AT (B)(6). HE DOES NOT RECALL WHAT TREATMENT HE RECEIVED BY THE EMS, BUT HE DID STATE THAT WHEN HE ARRIVED AT THE HOSPITAL HIS BLOOD GLUCOSE WAS 245MG/DL(?). HE STATED THAT HE WAS GIVEN SOMETHING TO EAT AND HE WAS DISCHARGED AFTER ABOUT 4 HOURS. HE WAS UNABLE TO RECALL WHAT TREATMENT HE RECEIVED AT THE HOSPITAL. HE WAS TOLD TO FOLLOW UP WITH HIS DR. UPON DISCHARGE HIS BLOOD GLUCOSE WAS 124MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312562 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190104-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization