BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS GI MONITOR CANCER ANTIGEN 19-9

    MDR report key: 15049658 · Received July 19, 2022

    Report

    Report Number
    2122870-2022-00034
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    NIG
    UDI-DI
    15099590231842
    PMA / PMN Number
    K033038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL PATIENT IDENTIFIER IS (B)(6). THE EXACT NUMBER OF PATIENTS INVOLVED IN THIS EVENT WAS NOT SPECIFIED. THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. DEVICE EVALUATED BY MFR: THE ACCESS GI MONITOR REAGENT WAS NOT RETURNED FOR EVALUATION. THE REAGENT PACK WAS DISCARDED BY CUSTOMER. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO CUSTOMER'S SITE. THE LSS CHECKED THE INSTRUMENT AND FOUND THAT ONLY PIPETTOR 2 WAS USED WITH THE ACCESS GI MONITOR ASSAY. A DEVIATION BETWEEN PIPETTORS WAS RULED OUT. NO NCR (NON CONFORMANCE REPORT) HAD BEEN REPORTED WITH REAGENT LOT 125013. THE LSS RECOMMENDED TO THE CUSTOMER FOLLOWING THE ACCESS GI MONITOR INSTRUCTIONS FOR USE IFU "MIX CONTENTS OF NEW (UNPUNCTURED) REAGENT PACKS BY GENTLY INVERTING PACK SEVERAL TIMES BEFORE LOADING ON THE INSTRUMENT. DO NOT INVERT OPEN (PUNCTURED) PACKS." IN CONCLUSION, A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH THE INFORMATION SUPPLIED. THERE IS NO EVIDENCE OF A REAGENT OR SYSTEM MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FALSE ELEVATED ACCESS GI MONITOR (CA 19-9) (LOT NUMBER 125013) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4). THE EXACT NUMBER OF PATIENTS INVOLVED IN THIS EVENT WAS NOT SPECIFIED. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, MULTIPLE PATIENTS SAMPLES RESULTS WERE AROUND 200 U/ML (AROUND LAST TWENTY TESTS OF THE REAGENT PACK 8600). THE ELEVATED PATIENT SAMPLES WERE RECHECKED WITH LOWER RESULTS. (NO DATA PROVIDED). THE CUSTOMER ALSO RECHECKED OTHER SAMPLES TESTED WITH DIFFERENT REAGENT PACKS BEFORE AND AFTER THE QUESTIONED ONE. THE RESULTS WERE AS EXPECTED. THE EXPECTED VALUES FOR THE GI MONITOR (CA 19.9) ASSAY ARE < 35 U/ML. THE CUSTOMER REPORTED SOME PATIENTS WERE ORDERED A CONTRAST ENHANCED COMPUTED TOMOGRAPHY BECAUSE OF THE HIGH ACCESS GI MONITOR RESULTS. NO ADDITIONAL IMPACT OR CHANGE TO PATIENT TREATMENT WAS REPORTED IN CONNECTION WITH THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON 6JUL2022. CALIBRATION PASSED ON 7JUL2022 USING REAGENT LOT 125013 AND CALIBRATOR LOT 124563. QUALITY CONTROL AT THE TIME OF THE EVENT WAS NOT PROVIDED FOR REVIEW. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO CUSTOMER'S SITE. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528008 ACCESS GI MONITOR CANCER ANTIGEN 19-9 SYSTEM,TEST,CARBOHYDRATE ANTIGEN(CA19-9),FOR MONITOR,MANAGE OF PANCREATIC CANCER NIG BECKMAN COULTER 387687 125013 15099590231842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other