BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10238411 · Received July 7, 2020

    Report

    Report Number
    3005862821-2020-00039
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    May 23, 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#: D190311-1). BECAUSE PATIENT DID NOT SEND BACK HER STRIPS, SO WE TESTED THE RETAINED STRIPS FROM WAREHOUSE. RETAINED STRIPS (LOT#: D190311-1) 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: 30~80; LEVEL HIGH: 200~310). RETURN METER W/ RETAINED STRIPS: 69/67 (LEVEL LOW) AND 246/247 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 73/70 (LEVEL LOW) AND 247/257 (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 8:00AM AT HOME. CALLER STATED THAT THE END-USER WAS UNRESPONSIVE, SO HE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 64MG/DL. A NORMAL RESULT FOR THIS TIME OF DAY IS USUALLY AROUND 96-115MG/DL. CALLER STATED THAT HE CALLED PARAMEDICS ABOUT 5 MINUTES AFTER TESTING, AND NO ADDITIONAL TEST WERE PERFORMED. NO FOOD MEDICATION OR DRINK WAS CONSUMED WHILE WAITING FOR PARAMEDICS. PARAMEDICS ARRIVED WITHIN 3 MINUTES AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 30MG/DL. PARAMEDICS ALSO TESTED THE END-USER USING THE PRODIGY METER AND RECEIVED A RESULT 67MG/DL. THE CALLER STATED THAT THE PARAMEDICS GAVE THE END-USER INSULIN, BUT HE IS UNSURE OF HOW MUCH OR WHAT KIND. THE CALLER ONLY PROVIDED ONE MEDICATION THAT THE END-USER IS CURRENTLY TAKING. THE PARAMEDICS TRANSPORTED THE END-USER TO (B)(6) HOSPITAL LOCATED AT 295 VARNUM AVE. UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS TESTED WITH THE HOSPITAL METER AND THEY RECEIVED A RESULT OF 30MG/DL. THE END-USER WAS ADMINISTERED INSULIN AND WAS STILL IN THE HOSPITAL WHEN THE CALLER CALLED TO INFORM PRODIGY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702699 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190311-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization