BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5737846 · Received June 21, 2016

    Report

    Report Number
    3005862821-2016-00032
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 20, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 16.2?A. THE CRITERIA IS <55?A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. PATIENT SENT BACK THE SUSPECTED STRIP, STRIP LOT# D150603-2. WE TESTED THE RETURNED STRIP RETURNED STRIPS, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 45/46 MG/DL; FOR LEVEL HIGH WERE 252/261 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS 4. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND SAME LOT NUMBER OF THE RETAIN STRIPS THAT PATIENT SENT BACK TO US. THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 49/49 MG/DL; FOR LEVEL HIGH ARE 273/274 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 05/12/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 6:50AM. PATIENT'S GRANDDAUGHTER CALLED IN STATING THAT PATIENT WAS ACTING STRANGELY AND MAKING STATEMENTS THAT DID NOT MAKE SENSE (LETHARGIC). SHE TESTED PATIENT'S GLUCOSE AND RECEIVED A READING OF 143MG/DL WITH THE PRODIGY METER. PATIENT'S DAUGHTER THEN CALL MEDICS AND UPON ARRIVAL MEDICS TESTED PATIENT'S GLUCOSE WITH A READING OF 40MG/DL. NO MEDICATIONS WERE TAKEN PRIOR TO THE EVENT. PATIENT CONSUMED 1 CUP OF ORANGE JUICE PRIOR TO THE MEDICAL ATTENTION EVENT. PATIENT'S NORMAL GLUCOSE READING AROUND THE TIME OF THE DAY OF THE EVENT IS 90-100MG/DL. PARAMEDICS WERE CALLED 5 MINUTES AFTER THE EVENT. PATIENT WAS GIVEN 1 CUP OF ORANGE JUICE WHILE WAITING ON MEDICS TO ARRIVE. MEDICS ARRIVED 10 MINUTES AFTER BEING CALLED. PARAMEDICS ADMINISTERED GLUCOSE AND ORANGE JUICE TO PATIENT. PATIENT WAS NOT TRANSPORTED TO ER. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393480 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150603-2

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GOES TO CANCER CENTER EVERY 6 WEEKS