MAUDE Adverse Event Report: BECKMAN COULTER IRELAND NAVIOS 10 COLORS/3 LASERS FLOW CYTOMETER; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	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	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.There were no instrument deficiencies identified for this event.Compensation adjustments did not resolve the issue.A review of the batch manufacturing record for clearllab 10c b cell tube, pn: b96805; lot-120321 was performed an no deviations or non-conformances were found that would impact performance.It was recommended that the customer continue to observe the performance of the b-cell tube compare to the other panel tubes.The customer will also continue running the 6-color add-on tube to confirm positive cd10 results with clearllab 10c per their laboratory decision.A new set of reagents was sent to the customer.The assignable cause could not be confirmed.The available information suggests that the even 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)(6).
Event or Problem Description
The customer reported positive cd10 in the clearllab 10 c b-cell tube and negative cd10 in the m1-tube when running it on their navios flow cytometer.The b-cell tube generated positive results for cd10 compared to negative results from the m1-tube from the same test panel for a bone marrow specimen.This issue has only occurred on this one patient sample.No other patient sample nor controls have exhibited the reported issue.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.To confirm the customer ran a 6-color add on protocol.The 6-color add-on tubes had the same cd10 clone, but in different dyes (cd10-pe, cd10-apc, and cd10-pc7).Cd10 was negative for all 6-color add-on tubes.

• 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: 12236603
• Report Number: 1061932-2021-00090
• Device Sequence Number: 3842121
• 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
• 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): 07/27/2021

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: 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: 06/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1