MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN, UNICEL® DXH SLIDEMAKER STAINER
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lab technician found that the previous patient slide in the sms (patient a) showed 90% of nonspecific lineage of blasts.The questioned slide showed 11% of blast also from nonspecific lineage of cells.Field application specialist (fas) collected patient result data from both instruments.Quality control and other patient results were not affected.The evidence reasonably suggests that carryover from previous patient with 90% of blast caused that the false 11% blast count in the reported patient.This was as a result of a bent dispense probe.Mod (b)(4) was performed on 21-feb-2020 to replace the bent probe.(b)(4).
Event or Problem Description
The customer reported that a patient sample (patient (b)(6)) showed "variantly' on the results from their unicel dxh 800 coulter cellular analysis system was run on the dxh sms for slide assessment.The slide result reported 11% blasts.Five days later (b)(6) 2020 a bone marrow biopsy was performed and was negative.This was for a follow up for a patient with multiple myeloma (type igg kappa) in remission.Patient was clinically asymptomatic.Patient (b)(6) results from the dxh instrument showed variant lymphocytic population which triggered the slide ordered on the dxh sms.The slide showed 11% blast.On the same day, the sample was run through a flow cytometry instrument and the examination of the sample was negative for blast.As a result of the positive slide results, the doctor performed a bone marrow biopsy which was negative for blasts.

• Brand Name: UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 9795964
• Report Number: 1061932-2020-00025
• Device Sequence Number: 14175688
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K162414
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN, UNICEL® DXH SLIDEMAKER STAINER
• Device Catalogue Number: 77522
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-1002/2019-007C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other