BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5942293 · Received September 12, 2016

    Report

    Report Number
    3005862821-2016-00071
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    August 14, 2016
    Report Date
    August 14, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 1.2UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. BECAUSE PATIENT DID NOT SEND BACK THE SUSPECTED STRIPS, ONLY METER, WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIPS LOT: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 51/54 MG/DL; FOR LEVEL HIGH ARE 256/248 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 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)(4) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 4:00PM. PATIENT'S((B)(6)) DAUGHTER ((B)(6)) CALLED IN STATING THAT (B)(6) WAS INCOHERENT, SWEATING AND PASSED OUT. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 393MG/DL. (B)(6)'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF TE EVENT IS 83-130MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AFTER TESTING WITH THE PRODIGY METER AND ARRIVED 15-20 MINUTES AFTER BEING CALLED. UPON ARRIVAL PARAMEDICS TESTED (B)(6)'S BLOOD GLUCOSE 2 TIMES WITH RESULTS OF 40MG/DL AND 63MG/DL. APPROXIMATELY 20 MINUTES PASSED BETWEEN TESTING WITH PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS PERFORMED 2 ADDITIONAL GLUCOSE TESTS WITH THE PRODIGY METER WITH RESULTS OF 96MG/DL AND 113MG/DL. PARAMEDICS GAVE TA 3 GLASSES OF ORANGE JUICE AND A SANDWICH. (B)(6) WAS NOT TRANSPORTED TO E.R. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594887 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151201-1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 150-200 5 UNITS| 201-250 7UNITS| 251-300 9 UNITS| 301-350 11UNITS| 351 -400 13UNITS| ADVAIR INHALER- AS NEEDED| ATENOLOL 25MG| BURMETANIDE 1MG (WATER PILL)| ELIQUIS 2.5MG (BLOOD THINNER)| INSULIN- LANTUS AND NOVOLOG:| LANTUS: 24 UNITS AM, 24 UNITS PM| SIMVASTATIN