BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5646170 · Received May 11, 2016

    Report

    Report Number
    3005862821-2016-00029
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 12, 2016
    Report Date
    May 10, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 1.5' 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 IN HOUSE STRIPS (STRIP LOT NUMBER: D150923-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 62/67 MG/DL; FOR LEVEL HIGH ARE 280/285 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 04/14/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016. PATIENT REPORTED THAT HE RECEIVED A HIGH READING ON THE PRODIGY METER. PATIENT STATED THAT HE DID NOT HAVE ANY SYMPTOMS. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 528MG/DL. PATIENT STATED THAT HE DID NOT CONSUME ANY FOOD PRIOR TO THE EVENT. PATIENT TESTED HIS BLOOD GLUCOSE APPROXIMATELY EVERY 2-5 MINUTES FOR A TOTAL OF 5 READINGS. THE RESULTS OF THE READINGS WERE: 528MG/DL, 540MG/DL, 291MG/DL, 202MG/DL, AND 191MG/DL. PATIENT' HAD A CHANGE IN HIS DIABETIC MEDICATION PRIOR TO THE EVENT (INVOKANA 100MG X1). PATIENT WENT TO THE HOSPITAL ON HIS OWN. PATIENT'S GLUCOSE READING UPON ARRIVAL AT THE ER WAS 112MG/DL. PATIENT WAS ADMITTED TO HOSPITAL. PATIENT'S BLOOD GLUCOSE LEVEL UPON DISCHARGE WAS 112MG/DL. HIS TOTAL STAY IN THE HOSPITAL WAS 3-4 HOURS. (B)(4) SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301245 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization GLIPIZIDE 10MG X2AM X1 PM