MAUDE Adverse Event Report: BECKMAN COULTER DXC 700 AU CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE

Device Problem Low Test Results (2458)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter customer technical support (cts) remotely assisted the customer to evaluate the dxc 700 au chemistry analyzer.The customer stated she does not preform maintenance.Cts had customer check the maintenance history, which indicated the electrodes and the tubing were changed in february 2024.There was no maintenance history on sample probe or buffer syringe.Cts advised the customer to replace sample probe and buffer syringe and preform enhanced manual clean and run precision.Replacement of the sample probe and buffer syringe resolved the issue.Section a2, a4 and a5: information not provided by customer.The beckman coulter internal identifier is case(b)(6).

Event Description

The customer reported the generation of erroneous low sodium (na) patient results on their dxc 700 au clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient demographics.The customer provided data for one (1) patient sample.

• Brand Name: DXC 700 AU CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA
• 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 92821 ; 7149613625
• MDR Report Key: 18961475
• MDR Text Key: 338748622
• Report Number: 9612296-2024-00104
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)230119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161837
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE
• Device Catalogue Number: B86444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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