MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC UNICEL DXH 520 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 520 CP HEMATOLOGY INSTRUMENT
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	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) was on site and confirmed what the customer reported.The fse suspected that the vacuum line from the syringe was pinched.To resolve the issue the fse flushed the vacuum line and wbc filter.Bec internal identifier - case (b)(4).
Event or Problem Description
The customer reported getting erroneous platelet (plt) results on a patient sample and intermittent syringe vacuum errors on their dxh 520 hematology instrument.Customer stated they have gotten the syringe vacuum error several times in the past month.Customer reported that they had one sample that was not giving the correct results on plt.The customer said the sample gave a result of 483 and when rerun resulted in 2353.The sample was sent to a reference laboratory and the result was consistent for the patient and considered correct.The results from the dxh 520 were not reported out of the laboratory.The customer reported that the dxh 520 had generated abnormal diff, cellular interference, and large cell messages.It could not be confirmed if both of the runs generated messages.Patient data was requested but has not been provided.The customer lab said that the initial complainant has the information and will be out of the office for several weeks.There was no impact or change to patient treatment as a result of this event.

• Brand Name: UNICEL DXH 520 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 11636161
• Report Number: 1061932-2021-00057
• Device Sequence Number: 19632407
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 04/08/2021

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 520 CP HEMATOLOGY INSTRUMENT
• Device Catalogue Number: B40602
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1