BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXI 600 IMMUNOASSAY ANALYZER

    MDR report key: 9637545 · Received January 28, 2020

    Report

    Report Number
    2122870-2020-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 28, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590369248
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER IS (B)(6). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE NOTED AIR IN THE LINE AT THE SUBSTRATE PUMP VALVE. THE FSE REPLACED THE SUBSTRATE PUMP VALVE AND PERFORMED A SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATIONS. THE CUSTOMER NOTED ERRONEOUS RESULTS POST VALVE REPLACEMENT; THE FSE RETURNED TO THE CUSTOMER SITE ON 10-JAN-2020 AND PERFORMED SUBSTRATE DECONTAMINATION. ERRATIC RESULTS WERE OBSERVED POST-DECONTAMINATION AND FSE COORDINATED WITH CUSTOMER TO DECONTAMINATE THE SYSTEM AGAIN. AFTER DECONTAMINATION, CUSTOMER NOTED THEIR QUALITY CONTROL WAS PASSING WITHIN ACCEPTABLE LIMITS. SYSTEM PERFORMANCE WAS VERIFIED WITH A BECKMAN COULTER NATIONAL PRODUCT SUPPORT SPECIALIST. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE HIGH ACCESS VITAMIN B12 RESULTS IS A HARDWARE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED PTH (ACCESS INTACT PTH) AND VITAMIN B12 (ACCESS VITAMIN B12) RESULTS FOR SIX PATIENTS ON THE LABORATORY'S DXI 500 IMMUNOASSAY ANALYZER (PART NUMBER A71461 AND SERIAL NUMBER (B)(4). NO PATIENTS WERE REPORTED TO HAVE HAD A CHANGE TO PATIENT TREATMENT BASED ON THE ERRONEOUS ACCESS INTACT PTH OR VITAMIN B12 RESULTS. THIS REPORT ADDRESSES THE ERRONEOUS ELEVATED VITAMIN B12 RESULT FOR THE PATIENT IDENTIFIED AS PATIENT (B)(6). THE INITIAL ACCESS VITAMIN B12 RESULT WAS >1525 PG/ML. THE CORRECTED RESULT WAS 592 PG/ML. THE CUSTOMER DID NOT PROVIDE REFERENCE RANGES OR EXPECTED VALUES. THE BECKMAN COULTER ACCESS VITAMIN B12 NORMAL REFERENCE RANGE IS 180-914 PG/ML. CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT SUPPLY QUALITY CONTROL INFORMATION FOR ACCESS VITAMIN B12; HOWEVER, THE CUSTOMER REPORTED THAT QUALITY CONTROL FOR OTHER ASSAYS WAS OUTSIDE OF RANGES AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON THE DATE OF THE INCIDENT FOR A CUSTOMER REPORT OF SUBSTRATE DISPENSE ERRORS. THE FSE OBSERVED AIR IN THE SUBSTRATE LINE. 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
    99541 DXI 600 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXI 600 ACCESS IMMASSY W/DUAL GANTRY 15099590369248

    Patients

    Seq Age Sex Outcome Treatment
    1