MAUDE Adverse Event Report: BECKMAN COULTER BECKMAN COULTER AU400 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU400

Device Problems High Test Results (2457); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

No patient's demographics were provided.A beckman coulter field service engineer (fse) was dispatched to the customer's site.The fse found an issue with r2 reagent dispensing unit.The fse replaced the r2 reagent probe, r2 reagent syringe driver and the r2 reagent transfer unit.No single part could be identified as the root cause.No further issue was observed.Replacement of the parts restored the instrument to functionality.

Event Description

A customer in the united states of america reported the generation of erratic urea results on beckman coulter au400 clinical chemistry analyzer.The erroneous patient result was not released outside the laboratory.There has been no report of any adverse event in connection with this event.The customer stated that the quality controls (qc) were run before testing the patient result.The qc recovery was within the laboratory specifications prior to event.

• Brand Name: BECKMAN COULTER AU400 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka, mishima JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5685426
• MDR Text Key: 46105701
• Report Number: 9612296-2016-00077
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981743
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU400
• Device Catalogue Number: 5427600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability