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

Model Number	DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter customer technical support (cts) remotely assisted the customer with their dxc 700 au chemistry analyzer and suggested that the customer replaced the y-tube and sample probe.The failure mode was identified as multiple hardware.Cts confirmed that replacement of the y-tube and sample probe resolved the issue.The analyzer is operational, and the customer is satisfied.Section a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of erroneously high sodium (na) patient results on their dxc 700 au clinical chemistry analyzer on (b)(6) 2024.The samples were repeated on another analyzer with lower results.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient demographics.The customer provided patient data.Note: reference beckman coulter identifier (b)(4) which addresses the erroneous results generated on (b)(6) 2024.

• Brand Name: DXC 700 AU CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 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 92821 ; 7149613625
• MDR Report Key: 20286951
• Report Number: 9612296-2024-00391
• Device Sequence Number: 7996324
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)220927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
• Device Catalogue Number: B86446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown