MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Test Result (2695)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per service request the field service engineer (fse) went to the customer site and found that there were bubbles in the sweep flow line.The fse replaced the sweep flow coil (pn 6807701) and its fitting to resolve the issue.The repairs were verified as per the service procedures.Per act diff 2 ifu pn 4237495bc, "when plt backgrounds fail beckman coulter recommends for the following: check the system for bubbles, starting with the fluid reservoir and moving on to the sample and diluent pumps.Remove the bath shield and run a cycle, observing the fluid in the baths if necessary.Repair any leaks that have caused the bubbles, whether tubing, fitting, or component.' (b)(4).
Event or Problem Description
The customer reported that the coulter act diff 2 analyzer generated high platelet (plt) results for one patient sample compared to a result from a dxh800 instrument.Per the field service engineer (fse) the customer reruns all of the samples in a dxh800 instrument.The customer found that the act diff 2 gave higher plt results without any flags or error messages.Per the fse, the act diff 2 instrument had also failed background checks prior to running the patient sample.The customer did not provide any printouts of the results.Erroneous results were not reported outside of the laboratory.There was no change or effect to patient treatment in connection with this event.

• Brand Name: COULTER AC T DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• MDR Report Key: 7523485
• Report Number: 1061932-2018-00033
• Device Sequence Number: 13759290
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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 Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: 6605500
• Device Lot Number: AK44130
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1