BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10238414 · Received July 7, 2020

    Report

    Report Number
    3005862821-2020-00040
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 6, 2020
    Report Date
    June 26, 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-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4) AND STRIP LOT#: D190812-1). BECAUSE PATIENT DID NOT SEND BACK HER STRIPS, SO WE TESTED THE RETAINED STRIPS FROM OUR WAREHOUSE. RETAINED STRIPS (LOT#: D190812-1) WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(4)) AND RETAINED METER(SERIAL#: (B)(4)) WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC. 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC. 2020), AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 45~95; LEVEL HIGH: 230 ~340). RETURN METER W/ RETAINED STRIPS: 75/79 (LEVEL LOW) AND 274/284 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 79/74 (LEVEL LOW) AND 278/288 (LEVEL HIGH). 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 (1.2 UA) MET ACCEPTANCE CRITERIA (< 55 UA). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE MATTER MIGHT RESULT FROM USER'S OPERATION OR PRESERVATION. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 4:30 AM AT HOME. THE CALLER STATED THAT THE END-USER WAS UNRESPONSIVE, SO HE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 167 MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS USUALLY BETWEEN 120-135 MG/DL. CALLER STATED THAT HE IMMEDIATELY CALLED PARAMEDICS AND ATTEMPTED TO GIVE THE END-USER WATER, NO FOOD OR MEDICATION WAS CONSUMED WHILE THEY WAITED FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED ABOUT 10 MINUTES LATER AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 33 MG/DL. PARAMEDICS TREATED THE END-USER WITH INSULIN (CALLER WAS UNSURE OF AMOUNT OR TYPE) A PEANUT BUTTER SANDWICH AND CRACKERS. PARAMEDICS DID NOT TEST THE END-USER WITH HER PRODIGY METER. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. SHE WAS TOLD BY THE PARAMEDICS TO EAT DRINK WATER AND TO TAKE HER INSULIN AT BEDTIME. THE END-USER TAKES 12 UNITS OF LEVEMIR DAILY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702701 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190812-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization