BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9391129 · Received November 29, 2019

    Report

    Report Number
    3005862821-2019-00068
    Event Type
    Injury
    Date Received
    November 29, 2019
    Date of Event
    November 4, 2001
    Report Date
    November 13, 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
    GA, 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 1.0UA. THE CRITERIA IS <55UA. 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 UNKNOWN, LABEL RUBBED OFF, LEFT ONLY 2 PCS INSIDE BOTTLE ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WAS 363 MG/DL, FOR LEVEL HIGH WAS 471 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. TWO RESULTS WERE OUT OF THE ACCEPTANCE RANGE. ALSO WE FOUND THE DESICCANT COLOR INSIDE THE RETURNED BOTTLE HAD CHANGED. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (OTHER BATCH, LOT NUMBER: D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/54 MG/DL, FOR LEVEL HIGH WERE 236/238 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 6:00PM AT HOME. END-USER STATED THAT SHE RECEIVED A RESULT OF HI MG/DL ON HER PRODIGY METER AND TOOK INSULIN BASED ON THAT RESULT. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 175- 200 MG/DL. THE END-USER SAID THAT ABOUT AND HOUR AND 15 MINUTES LATER SHE CALLED EMS DUE TO NOT BEING ABLE TO GET UP ON HER OWN AND SHE WAS INCOHERENT AND SWEATY. THERE WAS NO FOOD DRINK OR MEDICATION TAKEN WHILE WAITING FOR EMS ARRIVE. EMS ARRIVED WITHIN 7 MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 30MG/DL. EMS GAVE HER A GLUCOSE SOLUTION AND SALT WATER AND TRANSPORTED THE END-USER TO (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USER STATED THAT HER BLOOD GLUCOSE WAS AROUND 50- 55MG/DL. SHE WASN'T GIVEN ANYTHING BY THE HOSPITAL TO RAISE HER BLOOD GLUCOSE EXCEPT PEANUT BUTTER CRACKERS. SHE STATED THAT SHE WASN'T ADMITTED BUT WAS THERE FOR ABOUT 4-5 HOURS. LAB TESTS EKG AND OXYGEN TESTS WERE ALL NORMAL. SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY DR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185759 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization