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 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The customer performed their own troubleshooting over the phone with beckman technical support and found the sample probes were leaking.The customer replaced the sample probes to resolve the issue.The customer performed calibration and quality control, which all passed.The customer verified the analyzer resumed to normal operation.Section a2, a4, and a5: information not provided by customer.Beckman coulter internal identifier is: (b)(4).

Event Description

The customer reported three (3) patients had low results for sodium (na), chloride (cl), glucose (glu) and calcium (calc) on their dxc 700 au clinical chemistry analyzer.The customer repeated the samples on another au analyzer and results were still low and not released out of the laboratory.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics.The customer provided only results for sodium.

• 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 92821 8000
• 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 92821-8000 ; 7149613625
• MDR Report Key: 18995535
• MDR Text Key: 338997417
• Report Number: 9612296-2024-00113
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)200728
• 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: 03/27/2024

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: DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE
• Device Catalogue Number: B86444
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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