BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8963884 · Received September 5, 2019

    Report

    Report Number
    3005862821-2019-00045
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 8, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT METER WAS BROKEN BECAUSE OF METER CONNECTOR DEFORMATION. WHEN WE INSERTED STRIPS INTO METER, METER WAS ABLE TO TURN ON, BUT METER WAS NOT WORKING WHEN WE TRIED TO APPLY CONTROL SOLUTION OR BLOOD TO TEST STRIP. WE TESTED THE RETURNED STRIPS (STRIP LOT NUMBER:D181031-2 ) WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 68/62 MG/DL, FOR LEVEL HIGH WERE 251/245 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 . SO WE CONCLUDED THE METER WAS OUT OF WORK BECAUSE OF CONNECTOR DEFORMATION. THE PIN DEFORMATION OF THE CONNECTOR IS CAUSED BY THE REVERSE INSERTION OF THE TEST STRIP. USER OPERATION ISSUE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:00PM AT THE END-USER'S HOME. CALLER STATED THAT HER HUSBAND WAS NOT RESPONDING TO HER VERBALLY, WAS CLENCHING HIS FIST AND BREATHING SHALLOWLY. CALLER STATED THAT SHE TESTED HIM WITH HIS PRODIGY METER AN RECEIVED A RESULT OF 21MG/DL. CALLER THEN CALLED THE PARAMEDICS. NO FOOD OR MEDICATION WAS CONSUMED WHILE WAITING FOR MEDICAL ATTENTION, BUT HE DID EAT HONEY NUT CHEERIOS AND TAKE 60 UNITS OF TUOJEO PRIOR TO NEEDING MEDICAL ATTENTION. PARAMEDICS ARRIVED AROUND 15 MINUTES LATER AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 50MG/DL. THE PARAMEDICS ADMINISTERED GLUCOSE IN AN IV AND TRANSPORTED THE END-USER TO THE HOSPITAL. CALLER IS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN THEY ARRIVED AT THE HOSPITAL. THE END-USER DID NOT RECEIVE ANY TREATMENT FOR HIS BLOOD GLUCOSE WHILE AT THE HOSPITAL OTHER THAN THE GLUCOSE IV. THE END-USER HAD HIS MEDICATION CHANGED LANTUS TO TOUJEO 3 DAYS PRIOR TO SEEKING MEDICAL ATTENTION. THE END-USER WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DR. HE WAS TREATED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760411 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization