MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE

Catalog Number A25640

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.The fse replaced the luminometer and performed a system check.The system check failed with low washed mean.The fse noted a slow aspirate peri pump tube and replaced it.The washed system check was performed and was passing within specifications.The cause of the erroneous access ferritin results is due to a hardware malfunction; however, no one component can be implicated as the sole contributor in this event.

Event Description

The customer reported obtaining erroneous ferritin (access ferritin) results in association with the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system (serial number (b)(4)) for several patients.The customer stated that failing access ferritin qc prompted patient samples to be repeated.Upon repeat of the samples for access ferritin, the customer noted a difference of 60-70 ng/ml between the repeated result and the original result.The customer stated the erroneous access ferritin results were reported from the laboratory.No corrected reports were sent as the customer believed the repeated results were not different enough to be significant to patient care.There was no change or impact to patient care or treatment in association with the erroneous access ferritin results.The customer declined to provide patient data.Calibration and quality control (qc) data were not provided for review.The customer stated that qc recovery was within range prior to the event but was failing the following day.Multiple system checks were reported to be failing washed %cv and substrate mean.During troubleshooting with the customer technical support (cts), the customer changed new aspirate probes, tightened substrate fitting, and changed the substrate probe.The system check was repeated and continued to fail with each of the changes.The patient samples were plasma samples with no reported sample integrity issues.The customer did not supply sample handling and processing information and did not supply the sample centrifugation parameters such as speed, time, and temperature.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.

• Brand Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5526696
• MDR Text Key: 41225156
• Report Number: 2122870-2016-00163
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A25640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2009
• 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