MAUDE Adverse Event Report: BECKMAN COULTER PK7400-10 PK7400 AUTOMATED MICROPLATE SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	PK7400-10 PK7400 AUTOMATED MICROPLATE SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the pk7400 part number (pn) b53299 serial number (b)(6) had questionable fuzzy cytomegalovirus (cmv) results for sample id (b)(6) on (b)(6) 2025 and the front and back controls for cmv.The images were fuzzy with cmv+ results.Repeat results were not provided.Service was not dispatched.Beckman coulter customer technical support (cts) assisted the customer over the phone.Customer indicated the issue has been resolved with the provided phone troubleshooting.Customer indicated no issue with other assays on the same pk7400.Customer required no further assistance.There was no report of death or injury in connection with this event.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
Beckman coulter customer technical support (cts) evaluated the pk7400 chemistry analyzer over the phone and instructed the customer to replace diluted sample d syringe and probe, and reagent syringe.The issue was resolved.Section a2, a4 and a5: information not provided by the customer.The beckman coulter internal identifier is (b)(4).

• Brand Name: PK7400-10 PK7400 AUTOMATED MICROPLATE SYSTEM
• 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: 21253897
• Report Number: 9612296-2025-00554
• Device Sequence Number: 8056029
• Product Code: JJE
• UDI-Device Identifier: 14987666543344
• UDI-Public: (01)14987666543344(11)211123
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK180292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/28/2025

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: PK7400-10 PK7400 AUTOMATED MICROPLATE SYSTEM
• Device Catalogue Number: B53299
• 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: 01/01/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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