BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6844231 · Received September 6, 2017

    Report

    Report Number
    3005862821-2017-00092
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 3, 2017
    Report Date
    August 4, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER WAS ABLE TO TURN ON AND GIVING RESULTS, IT ALSO OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 2.3-A. THE CRITERIA IS <55-A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 51/51 MG/DL, FOR LEVEL HIGH WERE 244/245 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. 4. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, SO WE TESTED THE RETAIN STRIPS (SAME PATIENT'S STRIP LOT NUMBER: D160321-1) IN OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 48/48 MG/DL; FOR LEVEL HIGH WERE 238/231 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 12:00 PM AFTER THE END USER'S PRODIGY DIABETES METER MALFUNCTIONED AND WOULD NOT ALLOW HIM TO TEST. THE END USER WAS ATTEMPTING TO PERFORM A BLOOD GLUCOSE TEST AND THE METER SUBSEQUENTLY REVERTED TO THE SETTING MODE. HE WAS NOT EXPERIENCING ANY SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR HIS BLOOD GLUCOSE LEVELS HE VISITED THE ER. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE READING WAS 120 MG/DL. HE RECEIVED 50 UNITS OF LANTUS AND AFTER 30 MINUTES AT THE ER HE WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 90 MG/DL AND INSTRUCTED TO FOLLOW HIS INSULIN REGIMEN. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627308 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160321-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability ALLOPURINOL,| LANTUS 70 UNITS AM/PM.| LISINOPRIL,| TRICOR,| VALSARTAN,| ZENON,