MAUDE Adverse Event Report: BECKMAN COULTER, INC AU5800 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800-10

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter field service engineer (fse) evaluated the instrument and identified buildup on the outer cuvette wheel and cuvettes of unit 3 on the au5800 clinical chemistry analyzer.The buildup was significant enough to partially occlude the wash nozzles.Fse determined that wash station valves were faulty.Fse replaced the valves 18, 30 and 31 to resolve the issue.Fse verified system performance.There have been no further issues reported.(b)(4).

Event Description

Field service engineer (fse) reported that he was informed by the customer that the oxidant assay, a non-diagnostic urine drug screen adulterant test, was generating flagged results on patient samples on their au5800 clinical chemistry analyzer.No erroneous patient results were generated or reported.Customer halted testing on the unit until service could arrive.There is no change to patient treatment associated with this event.

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino,; nagaizumi-cho sunto-gun; schizuoka, mishima, jp-nota 41 ; JA
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5639022
• MDR Text Key: 44680800
• Report Number: 9612296-2016-00066
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112412
• 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: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800-10
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1