BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10424155 · Received August 19, 2020

    Report

    Report Number
    3005862821-2020-00045
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    June 26, 2020
    Report Date
    July 22, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841519007
    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). 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: 74/73 (LEVEL LOW) AND 265/259 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 73/69 (LEVEL LOW) AND 243/270 (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 (13.4 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 12:00PM AT HOME. CALLER STATED THAT THEY TESTED THE END-USERS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 97MG/DL. A NORMAL READING FOR THAT TIME OF DAY FOR HIM IS USUALLY AROUND 100MG/DL. THE CALLER STATED THAT THE END-USER HAD EATEN A BREAKFAST OF EGGS, BACON, TOAST AND WATER EARLIER THAT DAY. ABOUT 15 MINUTES AFTER TESTING WITH THE PRODIGY METER THE PARAMEDICS WERE CALLED DUE TO THE END-USER BEING SLIGHTLY UNRESPONSIVE AND HE APPEARED TO BE IN A DAZE. CALLER STATED THAT THE END-USER DID NOT TAKE ANY MEDICATIONS OR CONSUME ANY FOOD OR DRINK WHILE WAITING FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 44MG/DL. PARAMEDICS DID NOT TEST THE END-USER WITH HIS PRODIGY METER AND DID NOT TRANSPORT HIM TO THE HOSPITAL. CALLER DOES NOT RECALL WHAT MEDICATION THE PARAMEDICS GAVE THE END-USER, BUT SHE DID STATE THAT HE WAS GIVEN PEANUT BUTTER ON 2 GRAHAM CRACKERS. CALLER DOES NOT RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS PRIOR TO THE PARAMEDICS LEAVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890964 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 D190812-1 00384841519007

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization