MAUDE Adverse Event Report: BECKMAN COULTER 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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to evaluate the dxc 700 au chemistry analyzer.The fse observed a bent sample probe, bent ise mixer and the buffer valve fitting was loose.The fse tightened the loose fitting, replaced the sample probe and mix bars to resolve the issue.System performance was verified.No further issues were reported.Section a2, a4, and 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 false low ise (ion selective electrode) patient results on their dxc 700 au chemistry analyzer.All abnormal patient results were checked on another analyser and no abnormal results were reported outside the laboratory.There was no report of change to treatment, injury, or death associated with this event.The number of patients affected is unknown as the customer did not provide data or patient demographics.

• Brand Name: DXC 700 AU CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 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. kramer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17336148
• Report Number: 9612296-2023-00661
• Device Sequence Number: 6477333
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)190515
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/17/2023

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: 07/10/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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