MAUDE Adverse Event Report: BECKMAN COULTER DXC 700 AU CHEMISTRY ANALZYER; 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	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the dxc 700 au chemistry analyzer and performed troubleshooting.The fse determined the failure mode as multiple hardware components.The fse resealed the reference electrode, replaced ise buffer valve and ise sample pot which resolved 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 erroneously high patient results for ion selective electrode (ise), including sodium (na), potassium (k), chloride (cl), on their dxc 700 au clinical chemistry analyzer.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 following data for one (1) patient sample.

• Brand Name: DXC 700 AU CHEMISTRY ANALZYER
• 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. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17634066
• Report Number: 9612296-2023-00713
• Device Sequence Number: 17762563
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)180320
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2018
• 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