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

Catalog Number A78803

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

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

Event Date 12/11/2013

Event Type  malfunction  

Event Description

The affiliate stated the customer reported failed quality control (qc) and non-reproducible and elevated troponin i (access accutni) results, for one patient, involving the access accutni assay used in conjunction with the access 2 immunoassay system and access accutni calibrator.An initial result of 3.57 ug/l was obtained.The sample was analyzed, on the same instrument, two more times and produced results of 0.28 ug/l and 0.17 ug/l, respectively.The results were rejected by the customer as the laboratory utilized the istat points-of-care instrument for comparison.All three results were released from the laboratory.There was no report of patient consequence or change in patient treatment associated with this event.The patient's sample was collected in a becton dickinson (bd) lithium heparin tube and centrifuged at 4,000 rpm (rotations per minute) for ten minutes.Quality control is performed daily, once in the morning.The customer noted system check passed following the event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

There is no indication the access accutni device was returned for evaluation.The field service engineer (fse) verified system check reports and performed a passing level sense service test.The fse verified the transducer temperature was at optimum and inspected the incubator belt and completed required system tests to optimize the belt.The fse also verified wash carousel alignments.No hardware issues were identified.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 incident could not be determined with the available information.

• Brand Name: ACCESS® ACCUTNI?
• 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: 3548965
• MDR Text Key: 18568554
• Report Number: 2122870-2014-00001
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: A78803
• Device Lot Number: 329323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• 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