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

Model Number	TN,DXH 500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fields service engineer (fse) could not identify a specific malfunction or faulty part associated to this event.There was no repair or replacement of a component performed.The customer did not call back with a recurrence of the event as of (b)(6)2021.Section a patient information was not provided by the customer.Bec internal identifier case: (b)(6).
Event or Problem Description
The customer reported that their dxh 500 hematology instrument generated erroneously high platelet (plt) results on one patient with no flagging or alert on plt clumps the patient sample was initially run on a dxh 800 hematology instrument which generated r flags and a plt result of 14.0 and prompted the operator to review the results.They reran the patient on the dxh 500 generating much higher plt results (125.4) prompting for a manual slide review that coincided with the initial run on the dxh 800 and confirmed plt clumps on the sample.There was no indication of erroneous results being reported outside the laboratory raw data from the instrument was requested but not provided.Patient results were provided and assessed for this event.There was no report of change or effect to patient treatment.There was no adverse event reported as a results of this occurrence.

• Brand Name: DXH500 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; county clare ; EI
• MDR Report Key: 11700487
• Report Number: 1061932-2021-00060
• Device Sequence Number: 11674029
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1