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

Model Number AU5800-10 CHEMISTRY ANALYZER AU5800

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter customer technical support (cts) remotely assisted the customer with the au5800 chemistry analyzer.Cts confirmed that the customer replaced the sample probe then recalibrated and performed quality control with passing results.The failure mode is determined to be the sample probe.The sample probe was replaced to resolve the issue.Section a2, a4 and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported the generation of erroneous low ion selective electrolyte (ise) patient results on their au5800 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient data or demographics.

• Brand Name: AU5800 CHEMISTRY ANALYZER
• 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 MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA ; 7149613625
• MDR Report Key: 19047276
• MDR Text Key: 340114330
• Report Number: 9612296-2024-00121
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666541296
• UDI-Public: (01)14987666541296(11)130620
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800-10 CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• 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