MAUDE Adverse Event Report: BECKMAN COULTER PREPPLUS 2 WORKSTATION; AUTOMATED PIPETTING, DILUTING SPECIMEN PROCESSING FOR FLOW CYTOMETRIC ANALYSIS

Model Number	FINAL ASSY, PREP PLUS 2
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	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and confirmed what the customer had reported.There was no malfunction of the navios flow cytometry instrument, the malfunction occurred on the prep plus 2 sample handling device that was preparing the sample for testing.The fse observed that the prep plus 2 had a bent needle the needle would hit and twist slightly at the bottom of the antibodies, and would rub significantly in the wash station.Samples were not being prepared correctly for testing.To resolve the issue the fse replaced the needle.Bec internal identifier case (b)(4).
Event or Problem Description
The customer reported compensation concerns on samples run on their navios flow cytometry instrument part number b47905, serial number (b)(4).It is unknown how many patients were impacted.The information and data was requested from the customer but they were not able to provide specific information or data.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: PREPPLUS 2 WORKSTATION
• Common Device Name: AUTOMATED PIPETTING, DILUTING SPECIMEN PROCESSING FOR FLOW CYTOMETRIC ANALYSIS
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 11453238
• Report Number: 1061932-2021-00031
• Device Sequence Number: 3412493
• Product Code: PER
• UDI-Device Identifier: 15099590638191
• UDI-Public: (01)15099590638191(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: Other
• Device Model Number: FINAL ASSY, PREP PLUS 2
• Device Catalogue Number: 378600
• Device Lot Number: 80426939
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1