BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5537160 · Received March 31, 2016

    Report

    Report Number
    3005862821-2016-00012
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    January 14, 2016
    Report Date
    February 9, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 1.4A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAINED STRIPS (STRIP LOT NUMBER: D150330-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 51/49 MG/DL, FOR LEVEL HIGH ARE 250/256 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. TESTED THE RETURNED STRIPS (LOT NUMBER: D150330-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/49 MG/DL; FOR LEVEL HIGH WERE 268/266 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. THIS MFR REPORT IS RELATED TO IMPORTER REPORT# (B)(4).

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON 01/28/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 9:12AM. PATIENT'S DAUGHTER CALLED IN STATING THAT PATIENT WAS UNRESPONSIVE. THE READING ON THE PRODIGY METER AT THE TIME OF EVENT WAS 50MG/DL. PATIENT WAS EXPERIENCING SYMPTOMS OF UNRESPONSIVENESS, SWEATING AND HER EYES WERE ROLLED BACK. WHILE WAITING ON PARAMEDICS PATIENT'S DAUGHTER TRIED TO REVIVE HER WITH WATER, ORANGE JUICE, MILK AND SUGAR BUT PATIENT WAS INCOHERENT. DAUGHTER WAS ADVISED BY 911 AGENT NOT TO GIVE PATIENT ANY MORE SUGAR BUT DAUGHTER DISREGARDED ADVICE. FOUR TO FIVE ADDITIONAL TESTS WERE PERFORMED ON PATIENT BUT DAUGHTER WAS NOT SURE WHAT THE READINGS WERE. PATIENT'S NORMAL BLOOD GLUCOSE READINGS AROUND THE TIME OF THIS EVENT IS BETWEEN 120-150MG/DL. PARAMEDICS WERE CALLED AND ARRIVED 10-15 MINUTES AFTER BEING CALLED. UPON ARRIVAL PARAMEDICS TESTED PATIENT'S BLOOD GLUCOSE WITH THEIR METER WITH A RESULT OF 25MG/DL. PARAMEDICS ADMINISTERED A GLUCOSE IV TO PATIENT. PATIENT WAS NOT TRANSPORTED TO ER. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192922 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150330-1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention MULTIVITAMIN X1