BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6816085 · Received August 24, 2017

    Report

    Report Number
    3005862821-2017-00078
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 19, 2017
    Report Date
    July 21, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RETUNED METER, THE RESULT WAS 3.1 A. THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. BECAUSE PATIENT DID NOT RETURN HER STRIPS, SO WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (SAME BATCH AS PATIENT'S STRIP, LOT NUMBER:D160517-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/48 MG/DL; FOR LEVEL HIGH WERE 231/239 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 7:43 AM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER WAS TREMBLING AND HER BLOOD GLUCOSE READING DURING THE TIME OF THE MEDICAL EVENT WAS 341 MG/DL. SHE WAS TAKEN TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS 117 MG/DL. NO TREATMENT WAS ADMINISTERED WHILE SHE WAS IN THE ER DUE TO HER BLOOD GLUCOSE WAS WITHIN NORMAL RANGE. AFTER 5 HOURS SHE WAS DISCHARGED WITH A GLUCOSE READING OF 117 MG/DL AND INSTRUCTED TO GET PLENTY OF REST. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596544 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160517-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ATENOLOL 25 MG| CITALOPRAM 10 MIL| DULOXETINE 60 MG| GABAPENTIN 600 MG| HYDROCHLOROT 25 MG| LEVETIRACETAM 500 MG| METFORMIN 500 MG| MYRBETRIQ 25 MG| PEROCET 3/25 MG| TAVTIA XT 300 MG| TIZANIDINE 4 MG