BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10424156 · Received August 19, 2020

    Report

    Report Number
    3005862821-2020-00046
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 22, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4) AND STRIPS (LOT#: D170613-1). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (18.4 UA) MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 06/13/2017 AND WERE EXPIRED IN 06/2019. BECAUSE THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS, THE RETURNED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D190819-1) IN OKB'S WAREHOUSE AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), AND RESULTS (LEVEL LOW: 51/49; LEVEL HIGH: 250/256) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85 ; LEVEL HIGH: 220~330). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. PATIENT'S STRIPS ARE EXPIRED AND TESTING BLOOD WITH EXPIRED STRIPS MIGHT CAUSED OR CONTRIBUTED TO ERROR HIGH READINGS.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 1:00 AM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 275 MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 150-170 MG/DL. CALLER STATED THAT SHE TOOK HER INSULIN BASED OFF THE 275 MG/DL RESULT AND APPEARED TO BE IN A DAZE AND THEN BECAME UNRESPONSIVE. PARAMEDICS WERE CALLED ABOUT 30 MINUTES AFTER THE INITIAL TEST WITH THE PRODIGY METER. NO FOOD DRINK OR MEDICATIONS WERE CONSUMED WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED IN ABOUT 10 MINUTES AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 21 MG/DL. NO ADDITIONAL TESTS WERE PERFORMED WITH THE PARAMEDIC'S METER OR THE PRODIGY METER. CALLER SAID THAT NO TREATMENT WAS GIVEN BY THE PARAMEDICS. PARAMEDICS TRANSPORTED THE END-USER TO (B)(6) HEALTH SYSTEM HOSPITAL LOCATED AT (B)(6). UPON ARRIVAL THE END-USERS BLOOD GLUCOSE WAS TESTED, AND THEY RECEIVED A RESULT OF 20 MG/DL. CALLER STATED THAT THE END-USER WAS GIVEN NOVOLOG MIX INSULIN 30 UNITS BY THE HOSPITAL AND THE END-USER WAS AT THE HOSPITAL FOR 7 HOURS. CALLER STATED THAT NO ADDITIONAL TESTS WERE PERFORMED IN THE HOSPITAL. CALLER SAID NO DISCHARGE INSTRUCTIONS WERE PROVIDED AND THE END-USER HAD A BLOOD GLUCOSE OF 170 MG/DL WHEN SHE WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890965 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170613-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization