BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9391128 · Received November 29, 2019

    Report

    Report Number
    3005862821-2019-00065
    Event Type
    Injury
    Date Received
    November 29, 2019
    Date of Event
    September 24, 2019
    Report Date
    November 1, 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 1.1A. 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:D181031-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 141/143 MG/DL, FOR LEVEL HIGH WERE 318/326 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. THREE RESULTS WERE OUT OF THE ACCEPTANCE RANGE. AND WE FOUND THE DESICCANT COLOR HAD CHANGED ON PATIENT'S RETURNED STRIPS. 4. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER:D181031-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 68/66 MG/DL; FOR LEVEL HIGH WERE 261/259 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. BECAUSE THE DESICCANT COLOR CHANGED FROM PATIENT'S STRIPS, INDICATE THE STRIPS MIGHT GET MOISTURE. PATIENT USED THOSE STRIPS TO TEST BLOOD MIGHT CAUSED OR CONTRIBUTED TO HIGHER READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 2:30AM AT A HOTEL IN SAN ANGELO TX. END-USER STATED THAT SHE TOOK HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 138MG/DL. SHE THEN TOOK HER INSULIN BASED OFF THAT RESULT. THE END-USER STATED THAT SHE TOOK HER NIGHTTIME MEDICATIONS AND HAD A SNACK BEFORE BED, BUT SHE DOES NOT REMEMBER WHAT IT WAS. SHE STATED THAT ABOUT 5 HOURS AFTER TESTING WITH HER PRODIGY METER SHE WAS FOUND ON THE FLOOR UNABLE TO MOVE OR SPEAK AND THE EMS WAS CALLED. SHE IS UNSURE HOW LONG IT TOOK THE EMS TO ARRIVE. UPON ARRIVING THE EMS TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 49MG/DL. EMS DID NOT TEST WITH HER PRODIGY METER. SHE WAS GIVEN A GLUCOSE SOLUTION AND TRANSPORTED TO THE HOSPITAL. THE END-USER DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL JUST THAT IT WAS LOW. SHE WAS GIVEN GLUCOSE BY IV AT THE HOSPITAL. SHE WAS NOT TREATED FOR ANYTHING ELSE. END-USER STATED SHE WAS (B)(6) FOR ABOUT 4-5 HOURS. SHE STATED THAT SHE IS UNSURE OF WHAT HER BLOOD GLUCOSE WAS WHEN SHE WAS DISCHARGED FROM THE HOSPITAL. THE END-USER IS ON A SLIDING SCALE BUT DID NOT HAVE THAT INFORMATION WITH HER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185856 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization