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	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) inspected the instrument and confirmed the reported issue from the customer.The assignable cause of the reported event was a faulty o-ring at the probe.While replacing the o-ring the fse observed that there was dried blood on the top of the assembly and performed the cleaning function to the assembly as well.The instrument was then verified to meet the published performance specifications.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported higher platelet (plt) values than expected on patient samples that were run on their dxh 500 hematology instrument.The samples in question were sent to reference lab and confirmed to be erroneously higher on the dxh 500.There was no report of change or effect on patient treatment.The customer indicated that controls were failing to recover within the expected ranges (high plt), and attempted several times in order for the controls to pass.Once the controls passed, the customer began using the instrument to process patient samples.The customer reported that there were a number patient samples that had higher results for platelets than expected.The customer sent these samples to the reference lab and confirmed the plt values were higher on the dxh500 and 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: 11737832
• Report Number: 1061932-2021-00062
• Device Sequence Number: 14411260
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 04/19/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1