BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY VOICE

    MDR report key: 5777802 · Received July 8, 2016

    Report

    Report Number
    3005862821-2016-00034
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    April 15, 2016
    Report Date
    June 16, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 12.7. THE CRITERIA IS <55 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: D150825-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 68/66 MG/DL,FOR LEVEL HIGH ARE 276/268 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. RETURNED STRIPS TEST (STRIP LOT NUMBER:D150825-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/66 MG/DL, FOR LEVEL HIGH WERE 283/285 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.

    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 2:00PM. PATIENT'S REHAB SPECIALIST CALLED IN STATING THAT PATIENT'S BLOOD GLUCOSE WAS LOW. PARAMEDICS WERE CALLED 1 HOUR AFTER TESTING WITH THE (B)(4) METER. THE READING ON THE (B)(4) METER AT THE TIME OF THE EVENT WAS UNKNOWN. PARAMEDICS WERE CALLED 1 HOUR AFTER TESTING WITH THE (B)(4) METER. PARAMEDICS ARRIVED APPROXIMATELY 7 MINUTES AFTER BEING CALLED. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF THE EVENT IS 175MG/DL. REHAB SPECIALIST STATED THAT PARAMEDICS TESTED PATIENT'S GLUCOSE WITH THE PARAMEDIC'S METER AND IT WAS 20MG/DL LOWER THAN THE (B)(4) METER. PARAMEDICS TRANSPORTED PATIENT TO ER. UPON ARRIVAL REHAB SPECIALIST STATED THAT PATIENT'S GLUCOSE LEVEL WAS 20MG/DL LOWER THAN THE (B)(4) METER. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431636 PRODIGY VOICE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 D150825-1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CALCIUM