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

Model Number TN, UNICEL® DXH SLIDEMAKER STAINER

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 01/23/2020

Event Type  Injury  

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 9795964
• MDR Text Key: 195843219
• Report Number: 1061932-2020-00025
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K162414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN, UNICEL® DXH SLIDEMAKER STAINER
• Device Catalogue Number: 77522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-1002/2019-007C
• Patient Sequence Number: 1
• Patient Outcome(s): Other