BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5845784 · Received August 4, 2016

    Report

    Report Number
    3005862821-2016-00052
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 29, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.2?A. THE CRITERIA IS <55?A. PASS; METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK; METER MEMORY FUNCTION IN GOOD CONDITION, WAS ABLE TO STORE TEST READINGS IN THE MEMORY CORRECTLY; PATIENT SENT BACK 3 STRIPS (LOT NUMBER D151006-1) BUT THEY WERE ALL USED STRIPS, SO WE CAN ONLY TEST THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME LOT OF SUSPECTED STRIP, LOT NUMBER:D151006-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 64/62 MG/DL, FOR LEVEL HIGH ARE 281/278 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    (B)(4) RECEIVED A CALL ON 06/29/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED AROUND (B)(6) 2016 AROUND 10:00PM. PATIENT((B)(6)) CALLED IN STATING THAT HER PRODIGY METER HAD BEEN GIVING HER HIGHER THAN NORMAL RESULTS AND WAS NOT STORING READINGS IN THE MEMORY CORRECTLY. (B)(6) STATED THAT THE PRODIGY METER GAVE HER A HIGH RESULT WHICH PROMPTED HER TO GO TO THE ER. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 525MG/DL. (B)(6) NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 229-250MG/DL. (B)(6) STATED THAT UPON ARRIVAL AT ER HER BLOOD GLUCOSE LEVELS WERE IN THE LOW 200MG/DL. (B)(6) TOTAL STAY IN THE ER WAS 1 HOUR. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499662 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151006-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention NEURONTIN