BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9778839 · Received March 3, 2020

    Report

    Report Number
    3005862821-2020-00010
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 5, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE PATIENT DID NOT RETURN HER METER AND STRIPS, WE REVIEWED THE MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190221-2), AND NO NON-CONFORMITY WAS FOUND. THE METER WAS SHIPPED TO (B)(4) ON 07/15/2019, AND STRIPS WERE MANUFACTURED ON 02/21/2019 AND EXPIRED IN 02/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED, SO WE USED OUR IN HOUSE METER (SERIAL#: (B)(4)) TO TEST RETAINED STRIPS (SAME AS PATIENT STRIPS, LOT#D190221-2). THE CONTROL SOLUTION TEST WERE LEVEL LOW: 59/65 MG/DL; LEVEL HIGH: 223/230 MG/DL, ALL RESULTS MET THE ACCEPTANCE CRITERIA (GCS RANGE LEVEL LOW: 35~85; LEVEL HIGH: 200~310). 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

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 9:50PM AT HOME. CALLER STATED THAT THE END-USER TOOK HER BLOOD GLUCOSE ON HER PRODIGY METER AND RECEIVED A RESULT OF 215MG/DL. THE END-USER PERFORMED 1 MORE TEST WITH HER PRODIGY METER AND RECEIVED A RESULT OF 119MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS USUALLY AROUND 80-90MG/DL. ABOUT 5 MINUTES AFTER TESTING WITHER PRODIGY METER THE END-USER BECAME DISORIENTATED WAS SHAKING AND COULD NOT SPEAK SO THE EMS WAS CALLED. EMS ARRIVED WITHIN 5 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE AND RECEIVED A RESULT OF 49MG/DL. EMS DID NOT TEST THE END-USER WITH HER PRODIGY METER. THE END-USER WAS THEN TRANSPORTED TO (B)(6). THE END-USER WAS STILL AT THE HOSPITAL AT THE TIME OF THE CALL, SO NO TREATMENT HAD BEEN GIVEN YET. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242357 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190221-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization