BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10050176 · Received May 12, 2020

    Report

    Report Number
    3005862821-2020-00027
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 13, 2020
    Report Date
    April 30, 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#: D190424-1). RETURN AND RETAINED STRIPS (LOT#: D190424-1) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), RESPECTIVELY, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~90; LEVEL HIGH: 220~330). RETURN METER W/ RETURN STRIPS: 73/69 (LEVEL LOW) AND 258/256 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 72/76 (LEVEL LOW) AND 273/268 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 64/64 (LEVEL LOW) AND 247/255 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 60/55 (LEVEL LOW) AND 242/245 (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 (1.6 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 9:00AM AT HOME. THE CALLER STATED THAT THE END-USER WAS ACTING AS IF HE HAD LOW BLOOD SUGAR. HIS BLOOD GLUCOSE WAS TESTED WITH HIS PRODIGY METER AND HE RECEIVED A RESULT OF 79MG/DL. A NORMAL RESULT FOR THE END-USER AROUND THIS TIME OF DAY IS USUALLY AROUND 130-200MG/DL. THE CALLER STATED THAT ABOUT 15-20 MINUTES AFTER TESTING WITH THE PRODIGY METER THE PARAMEDICS WERE CALLED. CALLER STATED THAT THE END-USER DRANK A COKE WHILE WAITING ON THE PARAMEDICS, WHO ARRIVED WITHIN 15-20 MINUTES. THE PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 84MG/DL. PARAMEDICS DID NOT TEST THE END-USER WITH HIS PRODIGY METER. THE END-USER WAS TAKEN TO THE HOSPITAL BY PARAMEDICS. THE CALLER DID NOT RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS PRIOR TO THE PARAMEDICS LEFT. THE CALLER STATED THAT HE TOOK HIS DAILY MEDICATIONS THAT MORNING AND THAT HIS ENDOCRINOLOGIST CHANGED HIS INSULIN TO THE FOLLOWING AFTER SEEKING MEDICAL ATTENTION: 70UNITS OF INSULIN AT BREAKFAST 70UNITS AT LUNCH AND 40 UNITS AT DINNER. CALLER STATED THAT THEY PERFORMED A CONTROL SOLUTION TEST THE DAY MEDICAL ATTENTION WAS SOUGHT AND THE METER GAVE A RESULT OF 63MG/DL WHICH IS IN RANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509616 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190424-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention