MAUDE Adverse Event Report: BECKMAN COULTER DXC 600 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number UNICEL DXC 600 PRO PACKAGED

Device Problem Low Test Results (2458)

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

Event Date 03/10/2024

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter field service engineer (fse) evaluated the dxc 600 chemistry analyzer.The fse observed a leak in the probe due to a defective t-valve and the electrolyte injection cup (eic) bottom was broken.The fse replaced the t-valve and eic bottom to resolve the issue.System performance was verified, and the customer was satisfied.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is case(b)(4).

Event Description

The customer reported the generation of erroneously low ion selective electrode (ise) patient results, including sodium (na), potassium (k) chloride (cl) and glucose (glu) on their dxc 600 clinical chemistry analyzer.The customer repeated the samples on another analyzer with results considered correct.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 two (2) patient samples.

• Brand Name: DXC 600 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
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 18983509
• MDR Text Key: 338748814
• Report Number: 2050012-2024-00032
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 15099590310769
• UDI-Public: (01)15099590310769(11)161121
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

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: UNICEL DXC 600 PRO PACKAGED
• Device Catalogue Number: A10400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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