BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5924106 · Received September 2, 2016

    Report

    Report Number
    3005862821-2016-00062
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 13, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.5 ¿A. 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: D150427-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 56/61 MG/DL; FOR LEVEL HIGH ARE 260/258 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. PATIENT ALSO SENT BACK THE SUSPECTED STRIPS(STRIP LOT NUMBER: D150427-1). WE TESTED THE RETURNED STRIP WITH IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 46/45 MG/DL; FOR LEVEL HIGH WERE 243/251 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.

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON 07/13/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURED ON (B)(6) 2016 BETWEEN 9-10PM. PATIENT'S ((B)(6)) CAREGIVER/DAUGHTER IN-LAW ((B)(6)) CALLED IN STATING (B)(6) WAS HAVING SYMPTOMS OF TREMBLING. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 400MG/DL. ONE ADDITIONAL TEST WAS PERFORMED ON (B)(6) WITH THE PRODIGY METER WITH A RESULT OF 397MG/DL. (B)(6)'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 132-170MG/DL. PARAMEDICS WERE CALLED 30 MINUTES AFTER TESTING WITH THE PRODIGY METER AND ARRIVED 10 MINUTES AFTER BEING CALLED. UPON ARRIVAL PARAMEDICS TESTED (B)(6)'S BLOOD GLUCOSE WITH THEIR METER WITH A RESULT OF 264MG/DL. APPROXIMATELY 40-45 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. (B)(6) WAS TRANSPORTED TO ER BY PARAMEDICS. UPON ARRIVAL AT ER (B)(6)'S BLOOD GLUCOSE WAS 264MG/DL. NO TREATMENT WAS ADMINISTERED TO (B)(6) ENROUTE TO ER. (B)(6) WAS GIVEN 5 UNITS OF HUMULIN TO LOWER HER GLUCOSE AND 5 UNITS OF XANAX FOR ANXIETY. (B)(6)'S BLOOD GLUCOSE PRIOR TO RELEASE FROM ER WAS OVER 200MG/DL. (B)(6)'S TOTAL STAY IN ER WAS 1 HOUR. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576021 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150427-1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention ALPRAZOLAM-.5ML PER DAY .| AMLODIPINE-10ML,1 TABLET DAILY.| CREON-1 TABLET, TWICE PER DAY .| FUROSEMIDE - 20 ML, ONCE PER DAY .| LEVEMIR-30 UNITS PER DAY| LEVOTHYROXINE-.5 ML , 2 TABLETS IN THE MORNING.| LISINOPRIL -40ML, ONE TABLET .| PANTOPRAZOLE-40ML .ONCE PER DAY.| POTASSIUM-1 TABLET PER DAY| TRAMADOL-1 TABLET EVERY 6 HOURS AS NEEDED PER DAY.