BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11810928 · Received May 12, 2021

    Report

    Report Number
    3005862821-2021-00011
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 28, 2021
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS (DOC#: (B)(4)) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190503-1). THE METER WAS SHIPPED TO PDC ON 11-12-2019. RETURN METER (SERIAL#: (B)(4)) AND RETAINED ONE (SERIAL#: (B)(4)) WERE USED TO RE-EXAMINED THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (8.7 UA) OF THE RETURN METER MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 05-03-2019 AND WILL EXPIRE IN 05-2021. BECAUSE SUSPECTED STRIPS WERE NOT RETURNED TO OKB, RETAINED STRIPS (LOT#: D190503-1) WERE USED TO RE-TEST BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A02 AND EXP. BY 02-2022; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 12-2022), RESPECTIVELY. RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~90 ; LEVEL HIGH: 220~330), AND DESICCANTS OF THE STRIP VIAL ARE STILL FUNCTIONAL (ORANGE COLOR) EVEN THOUGH RETAINED STRIPS WERE EXPIRED. RETURN METER W/ RETAINED STRIPS: 73/75 (LEVEL LOW) AND 266/279 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 65/68 (LEVEL LOW) AND 287/289 (LEVEL HIGH) . AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED ITEMS WERE FOUND. IT IS UNCERTAIN ABOUT THE ACCURACY OF BGMS MANUFACTURED BY NON-OKB. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION AND INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 AROUND 7:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER BUT DOES NOT RECALL WHAT THE READING ONLY THAT IT WAS HIGHER WHEN COMPARED TO ANOTHER METER. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 210MG/DL. CALLER STATED THAT THE END-USER WAS INCOHERENT AND NOT RESPONDING TO HER NAME, SO PARAMEDICS WERE CALLED APPROXIMATELY 10 MINUTES AFTER TESTING WITH HER PRODIGY METER. CALLER STATED THAT NO FOOD DRINK OR MEDICATION WAS CONSUMED WHILE WAITING FOR THE PARAMEDICS WHO ARRIVED WITHIN 10 MINUTES. THE PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 35MG/DL. NO ADDITIONAL TESTING WAS DONE WITH THE PRODIGY METER. CALLER STATED THAT THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL AND HE DOES NOT RECALL WHAT TREATMENT SHE RECEIVED FROM THE PARAMEDICS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709763 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190503-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR AMLODIPINE| ATORVASTATIN| DONEPEZIL| GLIPIZIDE| LANTUS| LOSARTAN| LYRICA| TRAMADOL| ZOLPIDEM