MAUDE Adverse Event Report: BECKMAN COULTER IRELAND NAVIOS FLOW CYTOMETER SYSTEM; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN,NAVIOS 10 COLORS/3 LASERS
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	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that lymphoma cells from one sample appeared in another sample that was run subsequently on the navios flow cytometer.It was discovered when the customer re-ran a batch of samples for an unrelated reason, and found that the sample that previously had lymphoma cells now was completely negative.The field application analyst confirmed the reported failure.It is suspected that the high concentration of cells caused the backflush to not work properly and that there was a clog that was released into the second patient sample tube, this caused cross-contamination of the sample.The application analyst stated that from the speed with which the events from the first sample run was acquired, the samples concentration was above specified concentrations per the instruments instruction for use manual (ifu).The user did not adequately dilute the sample.In addition, a clog may have remained in the sample line during the subsequent sample run.The erroneous results were caused by an improper sample preparation.(b)(4).
Event or Problem Description
The customer reported that lymphoma cells from one sample appeared in another sample that was run subsequently on the navios flow cytometer.It was discovered when the customer re-ran a batch of samples for an unrelated reason, and found that the sample that previously had lymphoma cells now was completely negative.The discrepancy was discovered before the test result was released to the physician.There was no change or effect to patient treatment in connection to the event.

• Brand Name: NAVIOS FLOW CYTOMETER SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 11609426
• Report Number: 1061932-2021-00047
• Device Sequence Number: 3667204
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K130373
• 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): 04/01/2021

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: TN,NAVIOS 10 COLORS/3 LASERS
• Device Catalogue Number: A52103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1