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

Catalog Number A71456

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Patient demographics, such as patient age, date of birth, sex or weight, were provided.The beckman coulter (bec) field service engineer (fse) performed an aspiration test and noted aspirate probes one (1) and two (2) were not aspirating correctly.The fse replaced the peristaltic pump tubing.The fse performed a passing system check, high sensitivity system check and fifteen (15) replicate access accutni+3 precision run.The cause of the non-reproducible access accutni+3 results was due to a hardware malfunction.The worn peristalic pump tubing was not allowing for acceptable aspiration of the reaction vessels.(b)(4).All mdrs associated with this report: 2122870-2016-00144; 2122870-2016-00145.

Event Description

The customer reported non-reproducible troponin i (access accutni+3) results, above the normal reference range of the assay for three (3) patients.The customer reanalyzed the samples from two (2) patients on the same unicel dxi 800 access immunoassay system and obtained discrepant results, above and below the normal reference range of the assay.The customer reanalyzed one (1) sample on an alternate unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained lower results, within the normal reference range of the assay.Mdr2122870-2016-00144 addresses the results obtained on (b)(6) 2016.Mdr2122870-2016-00145 addresses the results obtained on (b)(6) 2016.The customer reported the elevated access accutni+3 results were not reported outside the laboratory.There was no report of change or impact to patient care or treatment.A beckman coulter (bec) field service engineer (fse) was dispatched to assess instrument performance.Level one (1) quality control (qc) was within the laboratory's established ranges prior to and after the reported event.Level three (3) qc was outside the customer's established ranges on (b)(6) 2016 but was within range upon repeat.After noting the non-reproducible access accutni+3 results, the customer changed the duckbill and performed a system check.The system check failed the washed, washed %cv and washed efficiency portions.Beckman coulter (bec) customer technical service (cts) assisted the customer in inspecting the aspirate probes and associated peristaltic pump tubing.The customer did not note any issues.Cts advised the customer to change the aspirate probes and repeat the system check.The customer changed the aspirate probes and repeated the system check.The system check failed the washed, washed %cv and washed efficiency portions.Samples are collected in plasma separator tubes.Samples are centrifuged at an unknown speed for eight (8) minutes.There was no report of sample integrity issues.

• 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: jeffery koll ; 1000lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5484355
• MDR Text Key: 39811997
• Report Number: 2122870-2016-00145
• Device Sequence Number: 0
• Product Code: MMI
• Reporter Country Code: US
• PMA/PMN Number: K023764
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A71456
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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