BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 4480433 · Received January 9, 2015

    Report

    Report Number
    3005862821-2015-00001
    Event Type
    Injury
    Date Received
    January 9, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 18, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CONCLUDED THAT THE METER AND STRIPS ARE OPERATED WITHIN SPECS. THE METER CURRENT TEST IS 0.9UA. THE CRITERIA IS <55UA - PASS. METER SETTING, AUDIO AND ALL BUTTONS WERE OK. TESTED THE SUSPECTED METER WITH SUSPECTED STRIP AND RETAINED STRIPS WITH IN HOUSE CONTROL SOLUTION. THE READINGS OF CONTROL SOLUTION TEST FOR LOW LEVEL ARE: 41/45/46/44 MG/DL; FOR HIGH LEVEL ARE: 235/240/262/255 MG/DL, THE REQUEST GCS RANGE IS LOW: 25-70 MG/DL; HIGH: 200-300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2014 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2014 AROUND 2-3AM. PATIENT (B)(6) STATED HER BLOOD GLUCOSE LEVEL HAD DROPPED TO 26MG/DL. PATIENT STATED SHE WAS HAVING SYMPTOMS OF STOMACH DISCOMFORT AND ITCHING. FROM PREVIOUS EXPERIENCE THE SYMPTOMS LED HER TO BELIEVE HER BLOOD GLUCOSE WAS DROPPING. PATIENT CALLED HER HUSBAND THEN PASSED OUT. PATIENT STATED THAT THE PRODIGY METER GAVE HER A FALSE READING OF 500MG/DL, SO SHE TOOK INSULIN AND HER BLOOD GLUCOSE DROPPED TO 26MG/DL. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 26MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AND PERFORMED A GLUCOSE TEST WITH A READING OF "LO". APPROXIMATELY 15 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PATIENT WAS NOT TRANSPORTED ER, BUT WAS GIVEN B50 INJECTION. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23970 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM NBW OK BIOTECH CO., LTD. 51850 D140225-1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PREDNISONE 5MG X 1| ESCITALOPRA| BUPRIPION 150MG X 1| APRIRIN 81MG X 1| CAPOTEN 600MG| TACROLIMUS 1MG X 1