MAUDE Adverse Event Report: BECKMAN COULTER ACCESS® ACCUTNI+3 REAGENT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number A98143

Device Problems High Test Results (2457); Calibration Problem (2890); Device Operates Differently Than Expected (2913)

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

Event Date 03/27/2014

Event Type  malfunction  

Event Description

The customer reported failed access® accutni+3 calibrations and elevated troponin i (access® accutni+3) results, for one patient, involving the access® accutni+3 reagent used in conjunction with the unicel® dxc 600i synchron® access® clinical system.The customer performed system diagnostics and noted system check passed within specification on all portions.The customer then performed a 10-replicate precision test using low level quality control material and noted results were acceptable and within specification.The customer discontinued analyzing patient samples after observing the discrepant patient results.The customer stated the discrepant results were not released from the laboratory.There was no impact to patient care associated with this event.The patient's sample was collected in a lithium heparin tube and centrifuged at 4,500 rpm (rotations per minute) for five minutes.The patient's sample was loaded through the closed tube aliquotter (cta).The customer indicated no system issues were noted.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

There is no indication that the access® accutni+3 device was returned for evaluation.The field service engineer (fse) performed a visual inspection of the instrument and work area and no system issues were noted.The fse proactively replaced the fluidics manifold, the wash pump, the precision pump, and the right side case fan (fan was inoperable).The fse also proactively replaced all the aspirate probes, rebuilt all of the mixer components, and cleaned inside the instrument.The fse verified the vacuum pump operation, the ultrasonics voltage setting, and the mixer speed.The fse also performed all applicable pipettor alignments.The fse noted high sensitivity (hs) system check failed and discovered air in the wash valve.The fse repaired the air leak and noted hs system check passed within specification.Additionally, the fse noted the instrument passed a 15-point precision test without any issues.Quality control (qc) was also acceptable, and the instrument was operating normally.Service activity performed was verified to meet the specified requirements per established procedures.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, a definitive cause of the discrepant result is unknown as quality control (qc), system checks, and precision study performed were within assay and instrument specifications.Beckman coulter continues to track and trend any incident related to this issue.

• Brand Name: ACCESS® ACCUTNI+3 REAGENT
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 3765602
• MDR Text Key: 19569350
• Report Number: 2122870-2014-00291
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121214
• 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: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: A98143
• Device Lot Number: 325487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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