MAUDE Adverse Event Report: BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	PK7312-02
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	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman coulter field service engineer (fse) assisted the customer bio-med engineer over the phone.The bio-med engineer indicated the issue was likely caused by the cell sample probe which was clogged/malfunctioned.The bio-med engineer confirmed the replacement of the cell sample probe and priming of the system resolved the issue.Therefore, the failure mode is use error.The customer did not performed the daily maintenance as instructed in user guide.Information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported erroneous/questioned results with o flags on their pk7300 analyzer.There was no report of change to treatment, injury or impact to patient care associated with this event.The customer did not provide any patient data or demographics.

• Brand Name: PK7300 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 8000
• MDR Report Key: 11653680
• Report Number: 9612296-2021-00122
• Device Sequence Number: 3547405
• Product Code: JJE
• UDI-Device Identifier: 14987666535721
• UDI-Public: (01)14987666535721(11)101201
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BK060024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: PK7312-02
• Device Catalogue Number: N3209000
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1