BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5629899 · Received May 4, 2016

    Report

    Report Number
    3005862821-2016-00028
    Event Type
    Injury
    Date Received
    May 4, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 6, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 1.4UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (STRIP LOT NUMBER: D150526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 64/59 MG/DL; FOR LEVEL HIGH ARE 279/281 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. PATENT ALSO SENT BACK THE SUSPECTED STRIPS, STRIP LOT NUMBER: D150526-1. WE TESTED THE RETURNED STRIPS, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/54 MG/DL; FOR LEVEL HIGH WERE 276/283 MG/DL. THE CONTROL SOLUTION RANGES REQUEST FOR THIS LOT 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 7:30PM. PATIENT (NP) STATED THAT SHE WAS PROMPTED TO CALL PARAMEDICS DUE TO HER BLOOD GLUCOSE BEING TOO HIGH. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 539MG/DL. PATIENT WAS EXPERIENCING SYMPTOMS OF LIGHT HEADINESS. PARAMEDICS WERE CALLED IMMEDIATELY AND ARRIVED IN APPROXIMATELY 3-5 MINUTES. PATIENT STATED THAT PRIOR TO CALLING PARAMEDICS SHE TOOK MEDICATION PRESCRIBED TO HER BY THE HOSPITAL. PATIENT DID NOT DISCLOSE WHAT TYPE OF MEDICATION IT WAS. UPON ARRIVAL, PARAMEDICS REQUESTED THAT PATIENT TEST HER BLOOD GLUCOSE WITH THE PRODIGY METER WHICH RESULTED IN 539MG/DL. PARAMEDICS THEN TESTED PATIENT'S GLUCOSE WITH THEIR METER WHICH HAD A RESULT 40 POINT LESS THAN THE PRODIGY METER. ONLY A FEW MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF THE MEDICAL ATTENTION IS 120-200. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286549 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150526-1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention