BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9160516 · Received October 7, 2019

    Report

    Report Number
    3005862821-2019-00050
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    September 2, 2019
    Report Date
    September 11, 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

    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 0.9A. 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 IN HOUSE STRIPS (STRIP LOT NUMBER:D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/62 MG/DL, FOR LEVEL HIGH WERE 255/247 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. PATIENT'S STRIP LOT # D160722-1 WAS MANUFACTURED ON JULY 22, 2016 AND EXPIRED ON JULY 22, 2018. STRIPS HAD BEEN EXPIRED FOR MORE THAN 1 YEAR. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    END-USER REPORTED MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 10AM AT THE SUPERMARKET. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE IN THE MORNING AND SHE RECEIVED A RESULT OF 225MG/DL, A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 90-130MG/DL. SHE STATED THAT SHE TOOK HER 16 UNITS OF INSULIN THEN HAD BREAKFAST THAT CONSISTED OF EGGS MEAT (DID NOT SAY WHAT KIND) AND FRUIT. THE END-USER TESTS 3 TIMES A DAY ON HER FINGERTIPS. END-USER SAID SHE WENT TO THE SUPERMARKET WHERE SHE PASSED OUT AND THE PARAMEDICS WERE CALLED. SHE WAS NOT GIVEN ANY FOOD OR MEDICATIONS WHILE WAITING FOR PARAMEDICS TO ARRIVE. UPON ARRIVAL THE PARAMEDICS TESTED HER BLOOD GLUCOSE SHE DID NOT KNOW WHAT THE RESULT WAS BUT SHE WAS TREATED WITH GLUCOSE THROUGH AN IV AND TRANSPORTED TO THE HOSPITAL. SHE DOES NOT KNOW WHAT HER BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL. SHE DOES NOT RECALL WHAT TESTS WERE DONE BUT STATED THAT SHE WAS GIVEN MORE GLUCOSE THROUGH HER IV. AFTER A FEW HOURS SHE WAS DISCHARGED WITH A BLOOD GLUCOSE OF 108MG/DL. SHE WAS TREATED AT (B)(6) MEDICAL CENTER: EMERGENCY SERVICES (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954791 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160722-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization