BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8963883 · Received September 5, 2019

    Report

    Report Number
    3005862821-2019-00038
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 7, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER WAS BROKEN BY 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 WITH OUR IN HOUSE METER AND CONTROL SOLUTION (STRIP LOT NUMBER: D181119-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/72 MG/DL, FOR LEVEL HIGH WERE 240/243 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

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HER HOME. END-USER STATED THAT SHE RECEIVED A RESULT OF LO WHEN TESTING HER BLOOD SUGAR. END-USER THEN STATED THAT SHE TRIED TESTING WITH HER PRODIGY METER 10 TIMES AND CONTINUED TO GET A READING OF LO. SHE THEN TRIED TO RAISE HER BLOOD SUGAR BY EATING CAKE COOKIE AND JUICE. SHE THEN SAID SHE STARTED SWEATING AND HAD FEELINGS OF NERVOUSNESS. END-USER STATED SHE TOOK METFORMIN 1000MG/DL. SHE PROCEEDED TO DRIVE HERSELF TO THE EMERGENCY DEPARTMENT WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 188MG/DL. SHE WAS NOT TREATED FOR HER BLOOD GLUCOSE DUE TO HER LEVEL BEING OK WHEN SHE ARRIVED AT THE HOSPITAL. SHE STATED THAT SHE WAS PRESCRIBED AMOXICILLIN 500MG/DL BUT DID NOT DISCLOSE WHY SHE WAS GIVEN THE ANTIBIOTIC. END-USER WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DR. SHE WAS TREATED AT (B)(6) HOSPITAL LOCATED AT (B)(6) FOR 5 HOURS AND WAS NOT ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760409 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181119-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization