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

Catalog Number A25640

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/10/2014

Event Type  Injury  

Event Description

The customer reported obtaining non-reproducible troponin (access accutni+3), creatine kinase mb (ckmb), and brain natriuretic peptide (bnp) results on (b)(6) 2014 for twenty (20) patients involving the access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system.A beckman coulter (bec) customer technical support (cts) recommended the customer to repeat all samples run during the questioned time frame and upon repeat on an alternate instrument, lower results were generated.The results were reported outside of the laboratory, and thirteen (13) patients were hospitalized.The customer did not provide the sample preparation information.The customer performed a passing accutni+3 calibration curve on (b)(6) 2014 with reagent lot 337217 and calibrator lot 332160.The instrument failed system check on (b)(6) 2014, while quality control (qc) and two calibrations failed on (b)(6) 2014.A bec field service engineer (fse) was dispatched to the customer site to evaluate the instrument.This is one of fifteen reports, and is associated with the results generated on (b)(6) 2014 for patient six who was hospitalized.

Manufacturer Narrative

The fse observed bubbles in the wash pump housing and replaced the seal and the o-ring.The fse found that the analyzer was dispensing a low volume of substrate.The fse rebuilt the substrate pump, replaced the substrate valve assembly, and changed the substrate pipettor tip.The system was verified with system check.Verification testing passed within instrument and assay specification.In conclusion, a specific hardware component cannot be determined with the information provided, although there was sufficient evidence to reasonably suggest the cause of the non-reproducible access accutni+3, ckmb, and bnp results was a hardware malfunction due to inefficient washing caused by one or more of the replaced parts.(b)(4).All related reports: 2122870-2014-00801, 2122870-2014-00802, 2122870-2014-00812, 2122870-2014-00813, 2122870-2014-00814, 2122870-2014-00815, 2122870-2014-00816, 2122870-2014-00817, 2122870-2014-00818, 2122870-2014-00819, 2122870-2014-00820, 2122870-2014-00826, 2122870-2014-00827, 2122870-2014-00828, 2122870-2014-00829.

• Brand Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4319427
• MDR Text Key: 5252365
• Report Number: 2122870-2014-00815
• Device Sequence Number: 1
• Product Code: MMI
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A25640
• Other Device ID Number: SOFTWARE VERSION 3.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR