MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. 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	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument and inspected the instrument and found no malfunction of the instrument.The customer ran other samples before and after the erroneous patient sample without any issue.It is suspected that the event is sample related, there was no instrument troubleshooting for this event.Customer agreed that this may be an isolated incident and has not called back to report a recurrence.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported incorrect platelet (plt) values on one patient sample that was run on their dxh 500 hematology instrument.There was no report of change or effect on patient treatment.The customer sent these samples to the reference lab and confirmed the plt values were higher on the dxh500.A manual smear was performed and the result correlated with the lower values were considered correct.

• 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: 12200542
• Report Number: 1061932-2021-00089
• Device Sequence Number: 5128320
• 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: 1(952)368-12
• 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): 07/20/2021

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: 06/28/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR