MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 81600N

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/29/2014

Event Type  malfunction  

Event Description

The customer reported an access 2 immunoassay system generated erroneous results for prostate-specific antigen (psa.) this mdr reports the results generated on (b)(6) 2014; please see mdr 2122870-2014-00435 for the results generated on (b)(6) 2014.On (b)(6) 2014, four patient samples were analyzed on the instrument and generated no-value results and indeterminate (ind) flags for both replicates of psa; the results were not reported out of the laboratory.The customer noted no hardware or event log messages on this day.The patient samples were later reanalyzed and numerical results were generated; the customer did not provide rerun results.Psa had been calibrated on (b)(6) 2014.The customer performed a system check on the instrument before the event, which passed with results within specifications; several system checks were performed after the event with both passing and out-of-range results.After the event, the customer recalibrated psa and reported that quality control (qc) results did not pass on an initial run and did pass upon repeat; the customer later reported erratic results were generated on subsequent qc runs.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse replaced preventative maintenance parts, but the instrument still failed system check.The fse checked the wash pump, precision pump and fluidics manifold, then replaced the parts due to cracks on acrylic blocks.The fse verified pump operation, mixer, assemblies, ultrasonics, alignments, and incubator belt calibration.The instrument was primed and a system check was performed, which passed service specifications.(b)(4).

• Brand Name: ACCESS 2 IMMUNOASSAY 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: 3898450
• MDR Text Key: 4544047
• Report Number: 2122870-2014-00451
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922823/A007
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Other Device ID Number: SW VERSION 3.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2011
• 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