BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6953837 · Received October 16, 2017

    Report

    Report Number
    3005862821-2017-00109
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 23, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 0.6¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/54 MG/DL, FOR LEVEL HIGH WERE 241/250 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. BECAUSE PATIENT DID NOT RETURN HER STRIPS, AND OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE. THE STRIP LOT # D150627-1 THAT PATIENT REPORTED WAS INCORRECT, AND SHOULD BE CORRECT TO LOT #D150617-1. THE STRIP LOT # D150617-1 WAS MANUFACTURED ON 06/17/2015 AND EXPIRED IN JUNE 17, 2017. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 12:00PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER STATED SHE FELT WEAK WAS INCOHERENT AND PASSED OUT. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 38 MG/DL. THE END USER WAS GIVEN SUGAR WATER AND A D50 SOLUTION TO ASSIST WITH RAISING HER BLOOD GLUCOSE. SHE WAS TRANSPORTED TO THE ER AND HER BLOOD GLUCOSE HAD SURGED TO 64 MG/DL. SHE WAS GIVEN AN ADDITIONAL IV WITH D50 SOLUTION AND ADMITTED TO THE HOSPITAL. AT THE TIME OF THIS CALL THE END USER WAS STILL IN THE HOSPITAL AND NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733085 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150617-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention HUMULIN R U500| LACTOPIL| METOPROLOL| NOVARTIS