BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5871141 · Received August 12, 2016

    Report

    Report Number
    3005862821-2016-00060
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    February 2, 2016
    Report Date
    July 7, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.6UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME STRIP LOT NUMBER:D150128-1 AS PATIENT'S RETURNED STRIPS). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 56/61 MG/DL, FOR LEVEL HIGH ARE 260/262 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. TEST THE RETURNED STRIPS FROM PATIENT (STRIP LOT NUMBER: D150128-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/53 MG/DL; FOR LEVEL HIGH WERE 269/275 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 11:00AM. PATIENT'S(MM) CAREGIVER(D) CALLED IN STATING THAT THE PRODIGY METER WAS PRODUCING INCONSISTENCY IN READINGS WHICH RESULTED IN THE INABILITY TO ADMINISTER SLIDING SCALE INSULIN. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 42MG/DL. A SECOND TEST WAS ADMINISTERED WITH THE PRODIGY METER WITH A RESULT OF 143MG/DL. MM'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 120-140MG/DL. STATED THAT MM HAD TAKEN A NORCO 325MG/DL TABLET PRIOR TO SEEKING MEDICAL ATTENTION. PARAMEDICS WERE CALLED WITHIN 2 MINUTES AFTER TESTING WITH THE PRODIGY METER AND ARRIVED 5 MINUTES LATER. STATED THAT UPON ARRIVAL THE PARAMEDICS TESTED WITH THEIR METER BUT HE WAS NOT SURE WHAT THE READING WAS. APPROXIMATELY 15 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. MM WAS TRANSPORTED TO ER BY PARAMEDICS AND WAS GIVEN AN IV FLUIDS WHILE ENROUTE. NOT SURE WHAT MM'S GLUCOSE READING WAS UPON ARRIVAL AT ER OR HOW MM WAS TREATED ONLY THAT MM RECEIVED A SALINE IV AND WAS GIVEN ANTIBIOTICS TO TREAT INFECTIONS. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524999 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150128-1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R NORCO 325MG 1 3XS DAY