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

Model Number FINAL ASSY PREP PLUS 2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and was able to confirm th reported issue.The cause of the issue was found to be the probe tubing popping off the probe base.The fse replaced the probe tubing with new tubing to resolve the reported issue and the waste well was replaced as a preventative measure.Bec internal identifier - (b)(4).

Event Description

The customer reported the prepplus2 randomly failed to add blood to daughter tube when preparing samples.Review of the histograms/results caused the user to question the results run on flow cytometry analyzer.The user confirmed that blood was not adequately added to some patient sample preparations.The customer was asked what specific results were impacted but the customer did not provide specific information regarding the results.Per the customer, some erroneous results were generated but were not reported out of the lab.The samples were re-prepared and re-run.There was no adverse event reported for this issue.There was no impact to patient treatment as a result of this event.

• Brand Name: COULTER PREPPLUS 2
• Type of Device: AUTOMATED PIPETTING, DILUTING SPECIMEN WORKSTATION FOR FLOW CYTOMETRIC ANALYSIS
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): TECAN SYSTEMS INC; 2450 zanker rd; san jose CA 95131
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17778239
• MDR Text Key: 323800565
• Report Number: 1061932-2023-00103
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Model Number: FINAL ASSY PREP PLUS 2
• Device Catalogue Number: 378600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1