BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 14520070 · Received May 26, 2022

    Report

    Report Number
    3005862821-2022-00005
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 20, 2022
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D210722B-1). THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON (B)(6) 2021 AND THE RETAINED ONE (SERIAL#: (B)(4)) WERE USED TO RE-EXAMINE THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OF BOTH METERS OCCURRED. STANDBY CURRENT (3.9 UA) OF THE SUSPECTED METER MET ACCEPTANCE CRITERIA (< 55 UA). SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2021-07-22. THEY WERE RE-TESTED BY SUSPECTED METERS WITH ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 0AH1A03 AND EXP. BY 2022-12-31; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 2022-12-31), RESPECTIVELY. RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA, AND DESICCANTS OF BOTH STRIP VIALS ARE STILL FUNCTIONAL (ORANGE COLOR). TEST RESULTS (LEVEL LOW: 62/61; LEVEL HIGH: 328/334) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75 ; LEVEL HIGH: 230~340). THERE IS NO QUALITY PROBLEMS FOUND ON THE RETURNED METER AND STRIPS. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED STRIPS AND MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON 4/28/2022 AROUND 2:00AM AT HOME. CALLER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 74MG/DL. A NORMAL RESULT FOR HER IS AROUND 150MG/DL. CALLER STATED THAT SHE STARTED TO FEEL SWEATY AND SHAKY ABOUT FIVE MINUTES AFTER TESTING SO SHE CALLED PARAMEDICS. CALLER STATED THAT SHE ATE MILK WITH SUGAR AND YOGURT WHILE WAITING FOR PARAMEDICS BUT DID NOT CONSUME ANY MEDICATIONS. PARAMEDICS ARRIVED ABOUT IN ABOUT 10-20 MINUTES, TESTED THE CALLER'S BLOOD GLUCOSE, AND RECEIVED A RESULT OF 121MG/DL. PARAMEDICS DID NOT TEST WITH THE CALLERS PRODIGY METER. PARAMEDICS DID NOT PROVIDE ANY MEDICAL TREATMENT IN REGARDS TO THE CALLER'S BLOOD GLUCOSE AND THEY DID NOT TRANSPORT HER TO THE HOSPITAL. CALLER WAS TOLD TO FOLLOW UP WITH HER DR. THE CALLER STATED THAT SHE IS PRESCRIBED 32 UNITS OF INSULIN BUT DID NOT SPECIFY THE TYPE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754344 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D210722B-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other GLIPIZIDE| LEVEMIR| METFORMIN