BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9361072 · Received November 22, 2019

    Report

    Report Number
    3005862821-2019-00064
    Event Type
    Injury
    Date Received
    November 22, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 1.0A. 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:D180814-1, ONLY 5 PCS). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/59 MG/DL, FOR LEVEL HIGH WERE 261/270 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. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S LOT NUMBER:D180814-1) WITH SUSPECTED METER AND OUR IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 68/64 MG/DL; FOR LEVEL HIGH WERE 259/265 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.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ABOUT A MONTH AGO, HE IS UNSURE OF DATE AND TIME HE WAS AT HOME. END-USER STATED THAT HE CHECKED HIS BLOOD GLUCOSE ON HIS PRODIGY METER AND RECEIVED A RESULT THAT WAS CLOSE TO 600MG/DL. HE DOES NOT REMEMBER THE EXACT READING. HE THEN TESTED THREE MORE TIMES WITH HIS PRODIGY METER AND THOSE RESULTS WERE HIGH AS WELL. HE STATED THAT A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 160-170MG/DL. HE THEN STATED THAT HE WAS NERVOUS AND PROCEEDED TO DRIVE HIMSELF TO THE HOSPITAL. HE DOES NOT REMEMBER WHAT HIS BLOOD GLUCOSE RESULT WAS UPON ARRIVING AT THE HOSPITAL. HE STATED HE DOES NOT REMEMBER THE NAME OF THE HOSPITAL ONLY THAT IT WAS IN DALLAS. END-USER STATED HE WAS IN THE HOSPITAL FOR 10 HOURS BUT WAS NOT ADMITTED. HE SAID HE WAS GIVEN INSULIN TO LOWER HIS BLOOD GLUCOSE LEVELS. WHEN HE WAS DISCHARGED HIS BLOOD GLUCOSE WAS 187MG/DL. THE END-USER DID NOT RECALL WHAT HIS DISCHARGE INSTRUCTIONS WERE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160308 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D180814-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization