BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5629881 · Received May 4, 2016

    Report

    Report Number
    3005862821-2016-00024
    Event Type
    Injury
    Date Received
    May 4, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 23, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 16.3-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: D150414-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 55/54 MG/DL; FOR LEVEL HIGH ARE 268/270 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25 APPROXIMATELY 70 MG/DL; LEVEL HIGH 210 APPROXIMATELY 310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. TESTED PATIENT'S RETURNED STRIPS (LOT NUMBER: D150414-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58 MG/DL; FOR LEVEL HIGH WERE 291 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25 APPROXIMATELY 70 MG/DL; LEVEL HIGH 210 APPROXIMATELY 310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    PRODIGY DIABETES CARE RECEIVED A CALL ON (B)(6) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURED ON (B)(6) 2016 AT 1:30AM. PATIENT'S DAUGHTER (RM) CALLED IN STATING PATIENT GOT A READING WITH THE PRODIGY METER OF 28MG/DL WHICH PROMPTED HER TO TAKE PATIENT TO HOSPITAL. PATIENT TOOK LANTUS, ATE CHOCOLATE AND DRANK A SODA BEFORE BEDTIME OF THE EVENT. (RM) STATED THAT PATIENT' BLOOD GLUCOSE WAS TESTED SEVERAL ADDITIONAL TIMES BEFORE BEING TAKEN TO THE HOSPITAL WITH THE FOLLOWING RESULTS: 227, 237, 147, 227, 97, 64, 155, 137, 71 AND 48MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF THE EVENT IS BETWEEN 130-135MG/DL. (RM) STATED THAT PATIENT WAS EXPERIENCING SIGNS OF SHAKINESS. PATIENT WENT TO THE ER ON HER OWN. PATIENT'S BLOOD GLUCOSE UPON ARRIVAL AT ER WAS 204MG/DL. NO ADDITIONAL GLUCOSE TESTING WAS PERFORMED WHILE AT THE HOSPITAL AND NO TREATMENT WAS ADMINISTERED. PATIENT'S TOTAL STAY IN HOSPITAL WAS APPROXIMATELY 1/2 HOUR. PRODIGY DIABETES CARE SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287709 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ANTENOLOL 25MG 1/2 PILL X1