BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9231516 · Received October 24, 2019

    Report

    Report Number
    3005862821-2019-00060
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 10, 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
    FL, 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 1.1UA. 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 STRIPS (OTHER LOT, STRIP LOT NUMBER:D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/53 MG/DL, FOR LEVEL HIGH WERE 239/248 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 TESTED THE RETURNED STRIPS TEST (LOT NUMBER: D170825-2) WITH IN HOUSE CONTROL SOLUTION AND RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 111/107 MG/DL; FOR LEVEL HIGH WERE 283/271 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 MG/DL. TWO RESULTS WERE OUT OF THE ACCEPTANCE RANGE. THE DESICCANT INSIDE THE PATIENT'S STRIP HAD CHANGED COLOR, WHICH INDICATES STRIPS MIGHT GET MOISTURE. AND ALSO THE STRIP WAS EXPIRED ON AUGUST 25, 2019. PATIENT USED MOIST AND EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 2:00 PM AT THE END-USERS HOME. CALLER STATED THAT THE END-USER WAS NOT ACTING LIKE HERSELF, SO SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 119 MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS AROUND 180 MG/DL. SHE STATED THAT THE END-USER WAS INCOHERENT AND HAD A LACK OF MOTOR SKILLS. THE CALLER THEN DECIDED TO TRANSPORT THE END-USER TO (B)(6) HOSPITAL LOCATED AT (B)(6). THE CALLER STATED THE WHEN THEY GOT TO THE HOSPITAL THE END-USERS BLOOD GLUCOSE WAS 70 MG/DL. THE CALLER STATED THAT THE END-USER WAS GIVEN ORANGE JUICE AND IS UNSURE OF ANY OTHER TREATMENT THE END-USER MAY HAVE RECEIVED AT THE HOSPITAL. THE END-USER WAS ADMITTED TO THE HOSPITAL FOR 48 HOURS. THE END-USER HAD A BLOOD GLUCOSE OF 180 MG/DL WHEN SHE WAS DISCHARGED, AND SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR. HER PRIMARY DOCTOR TOOK AWAY NOVOLOG AND NOVOLIN AND ADDED LINAGLIPTIN, AND REPAGLINIDE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025674 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170825-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization