BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 3817711 · Received April 30, 2014

    Report

    Report Number
    3005862821-2014-00006
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 3, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OK BIOTECH RECEIVED THE METER WITH STRIP (LOT NO D121221-2) ON (B)(4). WE CHECK THE RETURNED DEVICE: THE CURRENT TEST IS 1.1UA. THE STANDARD IS <55UA PASS. THE WORKING VOLTAGE TEST IS 399.9MV (400 +/- 30MV). METER'S SETTING, AUDIO AND ALL BUTTONS WERE OK. TESTED THE RETURNED METER AND STRIP WITH IN HOUSE CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. STRIP VIAL DESICCANT TEST (B)(4) IS FAILED. STRIP VIAL IS DAMP AND STRIP INSIDE IN MOIST OR EXPOSE TO MOISTURE.

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2014 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2014, AT 2:30PM. PATIENT (B)(6) STATED THAT HE WAS GETTING A HIGH READING ON THE PRODIGY METER OF 196MG/DL. PATIENT SAID HE BECAME ALARMED AND TOOK 4.6 UNITS OF INSULIN. PATIENT SAID HE NORMALLY TAKES 3 UNITS OF INSULIN. MEDICAL INTERVENTION TOOK PLACE WHEN PATIENT WENT TO AN UNRELATED DOCTOR'S APPOINTMENT. WHILE HE WAS THERE, HE TESTED HIS BLOOD GLUCOSE 2 MORE TIMES WITH THE PRODIGY METER, GETTING RESULTS OF 153MG/DL AND 173MG/DL. PARAMEDICS WERE CALLED. NO TREATMENT WAS GIVEN WHILE WAITING ON THE PARAMEDICS. PARAMEDICS ARRIVED AND PERFORMED A GLUCOSE TEST AND THE RESULT WAS 42MG/DL. APPROXIMATELY 15-20 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PATIENT WAS ONLY GIVEN AN IV BY PARAMEDICS. PATIENT WAS NOT SURE OF GLUCOSE RESULTS BEFORE PARAMEDICS LEFT. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE. IMP REF# 3008789114-2014-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258618 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SIMVASTATIN 40MG (BEDTIME)| RAMIPRIL 10MG X1 (MORNING)| BABY ASPIRIN X1| MELOXICAM 15MG X1 (MORNING)| LEVOTHROXINE 75MG X1 (MORNING)| LYRICA 225MG X2 (NOON AND BEDTIME)| CLOPIDOGREL 75MG X1 (MORNING)| CARBS INGESTED)| INSULIN PUMP (NOVOLOG 1-UNIT FOR EVERY 15G OF