MAUDE Adverse Event Report: BECKMAN COULTER DXC 500 AU CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE JP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) provided the customer phone support and indicated that the customer replaced the ise tubing to resolve the issue.The customer verified the analyzer resumed to normal operation.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported one patient had low sodium (na) results and low-quality control on two different dates on their dxc 500 au clinical chemistry analyzer.The low results were reported out the laboratory but were questioned by the doctor.The customer then sent the sample to another laboratory and obtained results matched the patient¿s profile.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 the results for this patient.Mdr-1 is for patient results generated on (b)(6) 2024.

• Brand Name: DXC 500 AU CLINICAL CHEMISTRY ANALYZER
• Common Device Name: 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: 20669298
• Report Number: 9612296-2024-00453
• Device Sequence Number: 12588879
• Product Code: JJE
• UDI-Device Identifier: 14987666545065
• UDI-Public: (01)14987666545065(11)240207
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K220977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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 500 AU CLINICAL CHEMISTRY ANALYZER WITH ISE JP
• Device Catalogue Number: C63520
• Device Lot Number: N/A
• 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: 10/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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