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

Model Number AU5800-10

Device Problems High Test Results (2457); Device Displays Incorrect Message (2591)

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

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.This mdr report is a result of that retrospective review.Manufacturing investigation: no parts were returned to the manufacturer for physical evaluation.The au5800 clinical chemistry analyzer was evaluated at the user facility by a beckman coulter field service engineer (fse).Instrument functional checks were performed which identified high fliers on ise cell 2 and ccs02 lever error message.The service documentation revealed that the an issue with the ise cell 2 buffer valve and a found that the detection window was obstructed by a foreign substance.The fse replaced the valve and cleaned the guide rail and sensor position slots which resolved the issue.No other problems were identified during the on-site evaluation.Following the service activity, the instrument was restored to full functionality.The investigation into the cause of the reported problem was able to confirm the failure mode.The fse identified ise cell 2 buffer valve issue and detection window obstruction which attributed to the reported event.Therefore, the complaint event was confirmed.

Event Description

It was reported by the customer that the ion-selective electrode (ise) cell 2 provided high flier results.Additionally, the customer reported experiencing cc lever error alarms regarding the ccs02 lever.There was no report of death or injury.

• Brand Name: AU5800 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 sunta-gun, mishima ; JA
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; m/s e1.se.01; brea, CA 92821-3796 ; 7149613796
• MDR Report Key: 7504089
• MDR Text Key: 108292940
• Report Number: 9612296-2018-00154
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666541296
• UDI-Public: (01)14987666541296(11)NO-DATA
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: AU5800-10
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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