MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number 5diff

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2017 the field service engineer (fse) was at the customer site and observed that the check valve at vl8 was not working.The fse also replaced the hemoglobin (hgb) led, and the rbc and wbc electrodes to resolve the reported problem.It could not be confimred if there was impact to patient results for this event.In an abundance of caution beckman coulter has submitted a report.Patient information was not provided by the customer.Bec internal identifier - (b)(4).

Event Description

The customer reported that their coulter act 5diff al hematology analyzer was experiencing high platelet counts.It could not be confirmed if it was controls or patient samples that were affected.The customer did not provide patient or control data.There was no report of change of patient treatment or affect to the patient.

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY 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: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3107520824
• MDR Report Key: 7988190
• MDR Text Key: 126102283
• Report Number: 1061932-2018-00040
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590576462
• UDI-Public: (01)15099590576462(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K032013
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5diff
• Device Catalogue Number: 6605581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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