MAUDE Adverse Event Report: BECKMAN COULTER IRELAND NAVIOS 10 COLORS/3 LASERS FLOW CYTOMETER; 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	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The clearllab 10c b-cell tube and m1-tube generated positive results for cd10 and the clearllab 10c t-tube generated positive cd2 results compared to negative results from confirmatory test panels.Similar results were obtained for two different lots of clearllab 10c b-cell and clearllab10c m1 reagent tubes and one lot of clearllab 10c t-tube reagent.The assignable cause could not be confirmed.The available information suggests that the event may be sample related.A review of the obi service history indicates that no further complaints have been logged by this customer at this time.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that cd10 was positive in the clearllab 10 c b-cell tube, cd10 in the m1-tube and cd2 in the clearllab t-tube on their navios flow cytometer.However, cd10 and cd2 were negative for all 6-color add-on tubes that the customer used to confirm the positive tests.These results were obtained on a peripheral blood sample for a patient that previously generated similar results on a bone marrow sample.Erroneous patient results were generated but were not reported out of the laboratory.There was no change or effect to patient treatment in connection to the event.This issue has only occurred on this one patient sample.No other patient sample nor controls have exhibited the reported issue.

• Brand Name: NAVIOS 10 COLORS/3 LASERS FLOW CYTOMETER
• 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: 12329419
• Report Number: 1061932-2021-00101
• Device Sequence Number: 14159661
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)170113
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: 07/23/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1