BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7284898 · Received February 21, 2018

    Report

    Report Number
    3005862821-2018-00012
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 14, 2018
    Report Date
    January 24, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 0.6A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D170322-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 177/178 MG/DL, FOR LEVEL HIGH WERE 394/374 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. STRIPS WERE MOIST. WE TESTED THE SUSPECTED METER WITH OUR RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D170322-1 ) WITH OUR CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 69/68 MG/DL; FOR LEVEL HIGH WERE 251/260 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. ACCORDING TO ABOVE TESTS, WE FOUND THE METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS FROM PATIENT'S STRIP MIGHT BECAUSE PATIENT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 8:00 AM AFTER THE END USER ALLEGES THAT HER PRODIGY DIABETES METER IS READING 100 POINTS HIGHER WHEN COMPARED TO A CONTOUR METER. THE END USER WAS FOUND UNRESPONSIVE AND SWEATING PROFUSELY ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 121 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 32 MG/DL. THE END USER RECEIVED AN IV TO ASSIST IN RAISING HER BLOOD GLUCOSE LEVEL AND AT THE POINT IT WAS DETERMINED THAT SHE DID NOT REQUIRE TRANSPORT TO THE ER. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128975 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D170322-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CLONAZEPAM 1MG| DULOXETINE 50-30'S| FIBRATE 160MG| HUMALOG| METFORMIN 500MG 4 X DAILY| METOPROLOL 50 MG| RANEXA 5MG| ROSUVASTATIN 40MG| SINGULAIR