MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number AC*T-DIFF F/ASSY,FINAL TEST LEVEL, 16 PARAMETERS

Device Problem Priming Problem (4040)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and confirmed the reported issue.The fse cleaned the sample syringe assembly and the probe wipe block assembly.The fse flushed the probe vacuum pathway and tightened the diluent filter connections to resolve the issue.

Event Description

The customer reported that the results generated on their act diff hematology instrument for two patient samples were erroneously high.Erroneous results were reported out of the laboratory.One of the patients were initially sent to the hospital emergency room but the recommendation was reversed once the customer identified an instrument problem.No other impact to patient or treatment was reported.Additional information about the impacted patient was requested.The customer technical specialist (cts) attempted to get the details regarding the patient who went to er but was unable to get additional information from the customer.

• Brand Name: COULTER ACT DIFF ANALYZER
• 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: 12140601
• MDR Text Key: 261007200
• Report Number: 1061932-2021-00083
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264734
• UDI-Public: (01)15099590264734(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC*T-DIFF F/ASSY,FINAL TEST LEVEL, 16 PARAMETERS
• Device Catalogue Number: 6706366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2021
• 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
• Patient Sequence Number: 1