BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9206459 · Received October 18, 2019

    Report

    Report Number
    3005862821-2019-00058
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 2, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DID NOT RETURN HIS METER, BUT ONLY HIS STRIPS. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER #(B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON (B)(6) 2018. WE TESTED THE RETURNED STRIPS (STRIP LOT NUMBER:D190131-1 ) WITH OUR IN HOUSE CONTROL SOLUTION AND IN HOUSE METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 69/69 MG/DL, FOR LEVEL HIGH WERE 239/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP LOT NUMBER: D190131-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 70/72 MG/DL; FOR LEVEL HIGH WERE 240/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8:25 AM AT THE END-USER'S HOME. CALLER STATED THEY FOUND THE END-USER UNRESPONSIVE AND THEY FELL OUT OF BED. THE CALLER STATED THAT SHE TESTED THE END-USER'S BLOOD GLUCOSE AND RECEIVED A RESULT OF 72 MG/DL. SHE THEN CALLED EMS WHO ARRIVED WITHIN 5 MINS. EMS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 34 MG/DL. EMS DID NOT TEST WITH THE END-USERS PRODIGY METER. THE END-USER WAS GIVEN AN IV WITH A GLUCOSE SOLUTION. HE WAS NOT TRANSPORTED TO THE HOSPITAL. THE END-USERS BLOOD GLUCOSE WAS 172 MG/DL WHEN THE EMS LEFT HIS HOME. THE END-USER IS ON A SLIDING SCALE FOR HIS INSULIN AND IT IS AS FOLLOWS: FIASP INSULIN FLEX PEN 111-161 MG/DL 1 UNIT, 162- 192 MG/DL 2 UNITS, 193-223 MG/DL 3 UNITS, 234-274 MG/DL 4 UNITS, 274-315 MG/DL 5 UNITS, 316-356 MG/DL 6 UNITS, 357- 397 MG/DL 7 UNITS, 398- 438 MG/DL 8 UNITS, 439-479 MG/DL 9 UNITS, OVER THAT 10 UNITS CALL EMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002110 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190131-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention