BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5537583 · Received March 31, 2016

    Report

    Report Number
    3005862821-2016-00016
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 7, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 1.5A. 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 RETAIN STRIPS (STRIP LOT NUMBER: D150416-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 50/49 MG/DL; FOR LEVEL HIGH ARE 282/271 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 TEST (STRIP LOT NUMBER: D150416-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 51/51 MG/DL; FOR LEVEL HIGH WERE 296/283 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 REPORT RELATED TO IMPORTER REPORT# (B)(4).

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON (B)(6) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURED ON (B)(6) 2016 AT 11:30PM. PATIENT'S CARETAKER ((B)(6)) CALLED IN STATING THAT THE PATIENT ((B)(6)) WAS EXPERIENCING SYMPTOMS OF INCOHERENCE, "DIAOPHORIC", UNSTEADINESS AND WAS UNABLE TO ANSWER QUESTIONS CORRECTLY. THE READING ON THE (B)(6) METER AT THE TIME OF THE EVENT WAS 123MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 130MG/DL. PARAMEDICS WERE CALLED WITHIN 5 MINUTES AND ARRIVED 15 MINUTES LATER. UPON ARRIVAL PARAMEDICS TESTED PATIENT' S GLUCOSE WITH THEIR METER WITH A RESULT OF 58MG/DL. APPROXIMATELY 15 MINUTES PASSED BETWEEN TESTING WITH THE (B)(6) METER AND THE PARAMEDIC'S METER. PARAMEDICS ADMINISTERED D50 IV PUSH, PATIENT WAS NOT TRANSPORTED ER. PATIENT ATE A PEANUT BUTTER SANDWICH, 3 GLASSES OF ORANGE JUICE AND MACARONI AND CHEESE WHILE WAITING ON PARAMEDICS TO ARRIVE. (B)(6) SENT REPLACEMENT AND PRE-PAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSYEM TO BE FORWARDED TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195727 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150416-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LEXATRO 20MG X1