BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5332174 · Received December 29, 2015

    Report

    Report Number
    3005862821-2015-00018
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    November 15, 2015
    Report Date
    November 17, 2015
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 16.4¿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 61/59 MG/DL; FOR LEVEL HIGH ARE 274/280 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. PATIENT TOLD THAT THE STRIP LOT WITH THEM WAS LOT NUMBER D150730-2. BUT THE SUSPECTED STRIPS DID NOT RETURNED TO OK BIOTECH, SO WE TESTED THE RETAINED STRIPS IN OUR WAREHOUSE (STRIP LOT NUMBER:D150730-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/60 MG/DL; FOR LEVEL HIGH WERE 281/281 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

    (B)(4) (OUR IMPORTER) RECEIVED A CALL ON (B)(6) 2015 REPORTING A MEDICAL INTERVENTION THAT OCCURED ON (B)(6) 2015 AT 8:00AM. PATIENT'S SPOUSE(CB) CALLED IN STATING THAT SHE PERFORMED A BLOOD GLUCOSE TEST ON PATIENT(TB) WITH A RESULT OF 300MG/DL. PATIENT WAS NOT DISPLAYING ANY SYMPTOMS. PATIENT'S SPOUSE CALLED BECAUSE OF BEING INSTRUCTED BY PATIENT'S PHYSICIAN TO REPORT INCIDENTS TO HIM/HER WHEN PATIENT'S BLOOD GLUCOSE LEVEL IS ABOVE 300MG/DL. EVENT HAPPENED ON SUNDAY, SO PATIENT CALLED EMS INSTEAD OF PATIENT'S PHYSICIAN. PATIENT'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 300MG/DL WITH THE PRODIGY METER. NO MEDICATION WAS TAKEN PRIOR TO THE EVENT. PATIENT'S NORMAL GLUCOSE READING AROUND THE TIME OF THIS EVENT IS AROUND 100MG/DL. PATIENT DRANK 7-UP PRIOR TO SEEKING MEDICAL ATTENTION. PARAMEDICS WERE CALLED WITHIN 1 HOUR AFTER TESTING WITH THE PRODIGY METER. PARAMEDICS ARRIVED AT PATIENT'S HOME WITHIN 15-20 MINUTES OF BEING CALLED. PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 109MG/DL. APPROXIMATELY 1 HOUR HAD PASSED IN BETWEEN INITIAL TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS ALSO PERFORMED A GLUCOSE TEST WITH THE PRODIGY METER WITH A RESULT OF AROUND 300-400MG/DL. WHILE WAITING ON PARAMEDICS PATIENT WAS BATHED AND PLACED IN A RECLINER. PARAMEDICS DID NOT ADMINISTER ANY TREATMENT. PATIENT WAS NOT TRANSPORTED TO HOSPITAL. NO CHANGES HAD BEEN MADE TO PATIENT'S DIABETIC MEDICATIONS BEFORE OR AFTER THE EVENT. ADDITIONAL NOTE: PATIENT PERFORMS GLUCOSE TEST 3 TIMES PER DAY VIA FINGERS. CONTROL SOLUTION TEST WAS PERFORMED BY CALLER ON THE DAY OF THE MEDICAL INTERVENTION AND RESULTS WERE WITHIN RANGE. PRODIGY PERFORMED 3 CONTROL SOLUTION TEST AND RESULTS WERE WITHIN RANGE. PDC IS FOLLOWING UP WITH REPORTER TO REQUEST RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856269 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 200-250 2 UNITS