MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A71457

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was at the customer's site and evaluated the instruments performance.The fse inspected the instrument and replaced pipettor one (1) piston, guide set and pressure monitor to address the event log messages displayed on the unicel dxi 800 access immunoassay system.Although the customer reported that the non-reproducible results were obtained from pipettor one, analysis of the patient results confirmed that the non-reproducible results were obtained utilizing all four reagent pipettors.As the non-reproducible results were obtained from all four (4) pipettors, the fse rebuilt pipettors two, three and four.The fse also rebuilt the sample pump to complete the repair.The fse successfully verified the performance of the unicel dxi 800 access immunoassay system after hardware parts replacement.In conclusion, the cause of this event is a hardware malfunction.Although repair of several hardware components resolved the issue, no one component can be implicated as the sole contributor to this event.

Event Description

The customer reported obtaining non-reproducible patient results on the majority of samples run on (b)(6) 2016 on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).The customer estimated that twenty five (25) results were released from the laboratory.There was no report of patient injury or change to patient treatment associated with this event.Calibration and quality control (qc) were within specification prior to the incident.Access free t4 qc was run following the event and recovered out of specification.Information on the patient sample collection and processing were not provided.No issues with sample integrity were reported by the customer.A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.

• Brand Name: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5661004
• MDR Text Key: 45368634
• Report Number: 2122870-2016-00275
• Device Sequence Number: 0
• Product Code: CEC
• Reporter Country Code: UK
• PMA/PMN Number: K023764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A71457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1