BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5537579 · Received March 31, 2016

    Report

    Report Number
    3005862821-2016-00013
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    January 19, 2016
    Report Date
    April 8, 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 TEST STRIP 52800, LOT# D130911-1 WERE EXPIRED ON 09/11/2015. THIS REPORT IS RELATED TO IMPORTER REPORT #(B)(4).

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.5A. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. THOUGH THE STRIP LOT NUMBER:D130911-1 WERE EXPIRED ON 09/11/2015, WE STILL TESTED THE RETURNED STRIPS WITH RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52 MG/DL; FOR LEVEL HIGH WERE 245 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~75 MG/DL; LEVEL HIGH 220~320 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 2:30AM. PATIENT AND HER HUSBAND CALLED IN STATING THAT SHE RECEIVED A HIGH READING OF 339MG/DL ON THE PRODIGY METER WHICH PROMPTED HER TO TAKE MORE INSULIN THAN NEEDED. PATIENT BECAME UNCONSCIOUS DURING THE NIGHT. PATIENT'S HUSBAND TRIED TO WAKE HER BUT COULD NOT. PATIENT'S HUSBAND TESTED PATIENT'S BLOOD GLUCOSE WITH A RESULT OF 39MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THIS TIME OF DAY IS BETWEEN 150-170MG/DL. PARAMEDICS WERE CALLED 5 MINUTES AFTER THE EVENT. PATIENT WAS GIVEN GLUCAGON AND A PEANUT BUTTER SANDWICH BY HER HUSBAND WHILE WAITING ON PARAMEDICS. PARAMEDICS ARRIVED 10 MINUTES AFTER BEING CALLED. PARAMEDICS PERFORMED A GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 81MG/DL. APPROXIMATELY 15 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS ALSO PERFORMED A GLUCOSE TEST WITH THE PATIENT'S METER WITH A RESULT OF 88MG/DL. PATIENT WAS NOT TRANSPORTED TO ER NOR WAS SHE GIVEN ANY TREATMENT BY PARAMEDICS. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2016-00013 TO SUBMIT INVESTIGATION RESULTS FOR THE SUSPECTED DEVICE AND TO CORRECT THE SUSPECT GLUCOSE METER SERIAL NUMBER. THE SERIAL NUMBER DOCUMENTED IN THE INITIAL REPORT, (B)(4) IS INCORRECT. IN THE INITIAL REPORT, THE SERIAL NUMBER SHOULD BE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193382 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D130911-1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PLAVIX 75MG X1