BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11264671 · Received February 2, 2021

    Report

    Report Number
    3005862821-2021-00004
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    December 25, 2020
    Report Date
    December 31, 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
    NJ, 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#: D191223-1). RETURN AND RETAINED STRIPS (LOT#: D191223-1) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 9AH1A99, EXP. BY FEB., 2022; LEVEL HIGH: BATCH# 9AH3A16, EXP. BY JAN., 2022), RESPECTIVELY, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~90; LEVEL HIGH: 240~350). RETURN METER W/ RETURN STRIPS: 64 (LEVEL LOW) AND 296 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 65/62 (LEVEL LOW) AND 303/302 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 64 (LEVEL LOW) AND 287 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 62/63 (LEVEL LOW) AND 305/292 (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 (1.5 UA) MET ACCEPTANCE CRITERIA (< 55 UA). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION FROM THE USER.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 8:00AM AT HOME. END-USER STATED SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND GOT A RESULT OF 198MG/DL. THE END-USER STATED THAT SHE TOOK 34UNITS OF HUMALOG DUE TO HER RESULTS. SHE STATED THAT SHE ALSO TOOK HER HIGH BLOOD PRESSURE MEDICINE THAT ARE AS FOLLOWS: COREG, NORVASC, AND ACCUPRIL. END-USER STATED THAT SHE THEN ATE CEREAL AND AROUND 30 MINUTES LATER FELT DIZZY AND WAS SWEATING. THE END-USER STATED THAT SHE THEN CALLED PARAMEDICS. WHILE WAITING FOR PARAMEDICS THE END-USER CONSUMED 2 PEPPERMINT PATTIES AND DRANK A GLASS OF ORANGE JUICE. PARAMEDICS ARRIVED WITHIN 10 MINUTES AND ACCORDING TO THE END-USER THEY PARAMEDICS SAID THEY DID NOT HAVE A GLUCOSE METER TO TEST HER BLOOD GLUCOSE BUT THAT THEY GAVE THE END-USER PEANUT BUTTER AND WAITED TILL SHE FELT BETTER BEFORE LEAVING. NO ADDITIONAL TESTS WERE PERFORMED WITH THE PRODIGY METER. THE END-USER STATED THAT THE PARAMEDICS DID NOT GIVE ANY TREATMENT AND ADVISED HER TO CALL BACK IF NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163661 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D191223-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR