MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT; HEMATOLOGY ANALYZER

Model Number AC*T DIFF 2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was on site and confirmed what the customer reported.The fse inspected the instrument and found that the instrument was contaminated.To resolve the issue the fse decontaminated the isntrument and verified operation by running controls that passed.Bec internal identifier (b)(4).

Event Description

The customer reported the act diff 2 hematology instrument generated erroneous high platelet (plt) results for one patient sample.The instrument also failed plt backgrounds.It was confirmed that erroneous results were not reported out of the lab.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT
• Type of Device: HEMATOLOGY ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 15458921
• MDR Text Key: 304004568
• Report Number: 1061932-2022-00060
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)170728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• 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