BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6790938 · Received August 13, 2017

    Report

    Report Number
    3005862821-2017-00079
    Event Type
    Injury
    Date Received
    August 13, 2017
    Date of Event
    July 22, 2017
    Report Date
    July 22, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    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 THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.0A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D161019-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/63 MG/DL, FOR LEVEL HIGH WERE 240/252 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 . WE TESTED THE SUSPECTED METER WITH RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, STRIP LOT NUMBER: D161019-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/68 MG/DL; FOR LEVEL HIGH WERE 257/250 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 .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 9:30 AM DUE TO RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PASSED OUT AND HER BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 73 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 43 MG/DL. THE END USER WAS TRANSPORTED TO THE ER AND COULD NOT RECALL IF THE PARAMEDICS ADMINISTERED ANY TYPE OF TREATMENT. UPON ARRIVAL TO THE ER THE END USER'S BLOOD GLUCOSE WAS 93 MG/DL AND NO TREATMENT WAS WARRANTED DUE TO HER READING WAS WITHIN NORMAL RANGE. AFTER 7 HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 105 MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571085 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161019-2

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention AMITIZA 8 MG| LASIX 40 MG| LEVOTHYROXINE 50MG| METROPROLO SUCCIRATE 50 MG| PROBIOTIC| SINEMET 25-250 MG 3TIMES A DAY| TRADJENTA 5 MG| TRESIBA 4 UNITS