MAUDE Adverse Event Report: BECKMAN COULTER IRELAND DXH500 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The field service engineer (fse) confirmed that the instrument failed repeatability for (plt) platelet parameters, generating erroneous high and low plt results that were not flagged.The fse inspected the instrument and found a leak at the probe rinse head caused by loose vacuum tubing.He reattached the loose vacuum tubing at the probe to resolve the issue.Bec internal identifier - (b)(6).
Event or Problem Description
The customer reported that repeatability failed for the platelet (plt) parameter on the dxh500 hematology instrument.Customer reported that there were less than five patient sample results impacted.There was no report of death, injury, or change to patient treatment as a result of this event.There was no indication of erroneous results being reported outside the laboratory.

• Brand Name: DXH500 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o'callaghan's mills; co. clare ; EI
• Manufacturer (Section G): BIT GROUP FRANCE; rue de la valsière; parc euromédicine ii; montpellier cedex 34090 ; FR 34090
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 15258410
• Report Number: 1061932-2022-00053
• Device Sequence Number: 5745997
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN DXH 500
• Device Catalogue Number: B40601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown