BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 11271643 · Received February 3, 2021

    Report

    Report Number
    2122870-2021-00003
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 3, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER IS (B)(4). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE ON (B)(6) 2020 AND (B)(6) 2021. THE FSE FOUND WASH PUMP BELT WAS TIGHT AND REPLACED IT. PINCH ROLLERS SHOWED HEAVY MOVEMENT AND INCUBATOR BELT WAS ALIGNED AND PINCH ROLLERS CLEANED. THE FSE PERFORMED INCUBATOR BELT CALIBRATION AND PERFORMED DECONTAMINATION OF WASH BUFFER RESERVOIR AND SUBSTRATE. AFTER SERVICING THE INSTRUMENT, THE FSE VERIFIED THE SYSTEM PERFORMANCE WITH SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK THAT BOTH PASSED ON (B)(6) 2021. IN CONCLUSION, THERE IS SUFFICIENT EVIDENCE PROVIDED TO REASONABLY SUGGEST A HARDWARE MALFUNCTION WAS THE LIKELY CAUSE OF THIS EVENT. THE PRIMARY FAILURE MODE WAS IDENTIFIED AS A DEFECTIVE WASH PUMP BELT.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING ONE ERRATIC TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE ORIGINAL HSTNI PATIENT RESULT WAS 0.00 NG/ML ON (B)(6) 2021 AT 15:10 HOURS AND A SECOND SAMPLE RESULTED ELEVATED WITH 0.120 NG/ML AT 16:05 HOURS. CUSTOMER REPORTED THAT THE PATIENT HAD FIVE PREVIOUS 0.00 NG/ML RESULTS. NO DATA PROVIDED FOR THIS PATIENT. THE PATIENT WAS ALREADY ADMITTED TO THE HOSPITAL PRIOR TO OBTAINING RESULTS. PATIENT RECEIVED AN ECG (ELECTROCARDIOGRAM) WHICH SHOWED NO CHANGES AND LATER RECEIVED CATHETERIZATION (DUE TO THE ELEVATED ACCESS HSTNI RESULT) THAT SHOWED NO EVIDENCE OF AN OBSTRUCTED HEART LESION. PATIENT WAS TESTED AT THE HOSPITAL AFTERWARDS FOR ANXIETY CONTROL AND DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED. CUSTOMER OBTAINED FAILED SYSTEM CHECKS SINCE (B)(6) 2021. HOWEVER CUSTOMER CONTINUED TO USE INSTRUMENT WITH FAILING SYSTEM CHECKS. A PASSING HSTNI CALIBRATION WAS OBTAINED ON (B)(6) 2020 USING REAGENT LOT 922062 AND CALIBRATOR LOT 921857. QC DATA SHOWS NO ISSUES AT THE TIME OF THE EVENT. ZONE TEMPERATURES WITHIN RANGE ON (B)(6) 2021. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(6) 2020 AND (B)(6) 2021. THE FSE FOUND WASH PUMP BELT WAS TIGHT AND REPLACED IT. PINCH ROLLERS SHOWED HEAVY MOVEMENT AND INCUBATOR BELT WAS ALIGNED AND PINCH ROLLERS CLEANED. THE FSE PERFORMED INCUBATOR BELT CALIBRATION AND PERFORMED DECONTAMINATION OF WASH BUFFER RESERVOIR AND SUBSTRATE. SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK PASSED ON (B)(6) 2021. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENTRIFUGATION TIME AND SPEED, STORAGE OR HANDLING WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172133 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other