MAUDE Adverse Event Report: BECKMAN COULTER DXC 700 AU CLINICAL 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	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the customer reported obtaining high glucose (glu) patient results for fifty-five (55) patients on their dxc 700 au clinical chemistry analyzer.The customer repeated the patient samples and obtained results considered correct.The customer reported the initial high results out of the laboratory; however, they were amended later.There was no change to treatment, injury or death associated with this event.The customer did not provide patients demographics.The customer provided the data for 55 patients in the attachment.
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the dxc 700 au clinical chemistry analyzer and replaced multiple syringes including the sample s syringe, the reagent r1 and r2 syringes and the wash syringe to resolve the issue.The fse performed calibration and quality control, which all passed.The fse verified analyzer resumed normal operation.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).Section e1, initial reporter telephone number is (b)(6).

• Brand Name: DXC 700 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: 17607351
• Report Number: 9612296-2023-00709
• Device Sequence Number: 6125457
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)220418
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/23/2023

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
• 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: 08/10/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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