BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5986199 · Received September 29, 2016

    Report

    Report Number
    3005862821-2016-00074
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 18, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 1.3. THE CRITERIA IS <55. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME BATCH OF SUSPECTED STRIP FROM PATIENT: D151019-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 58/59 MG/DL; FOR LEVEL HIGH ARE 272/266 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. WE TESTED THE RETURNED STRIPS FROM PATIENT (STRIP LOT NUMBER:D151019-1, RECEIVED ONLY 3 STRIPS IN ONE VIAL FROM PATIENT). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56 MG/DL; FOR LEVEL HIGH WERE 259 MG/DL. THE REQUEST 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

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON (B)(6) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 2:40 PM. PATIENT ((B)(6)) CALLED IN STATING THAT SHE WAS DOUBTING THE ACCURACY OF HER METER DUE TO THE HIGH BLOOD GLUCOSE RESULTS SHE WAS RECEIVING. (B)(6) WAS EXPERIENCING SYMPTOMS OF HEADACHES. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 258 MG/DL. (B)(6) NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 130-200 MG/DL. (B)(6) DID NOT CONSUME OR TAKE ANY MEDICATIONS PRIOR TO THE EVENT. (B)(6) WENT TO THE ER ON HER OWN. (B)(6) BLOOD GLUCOSE READING UPON ARRIVAL AT THE ER WAS 144 MG/DL. (B)(6) RECEIVED NO TREATMENT AT ER. (B)(6) BLOOD GLUCOSE READING PRIOR TO DISCHARGE FROM ER WAS 149 MG/DL. (B)(6) TOTAL STAY IN THE ER WAS 3-4 HOURS. (B)(6) WENT TO (B)(6). (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638910 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151019-1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention