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 Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the dxh520 instrument.He anew lot of controls for the customer and also suspected that a recently replaced main board could have contributed to the issue.The fse also adjusted the mean channel of the rbc latex and replaced the main card.He the ran daily checks, repeatability, carryover, latex and qc successfully.Patient information was not provided by the customer.Bec internal identifier case (b)(4).
Event or Problem Description
The customer reported getting erroneous high platelet (plt) results on three (3) patients and qc while using their dxh 520 hematology instrument.Erroneous results were not reported out of the laboratory, there was no impact or change to patient treatment as a result of this event.The customer ran the qc vials on the morning of the occurrence and they passed, even thought they were expired.The customer began running samples and 3 of the patient samples had high plt results, the customer mixed the samples and re-ran them.The second plt result was higher than the first run.The customer did not report the results out and sent the samples out to get tested elsewhere.The results of the last run were requested but the customer said they did not have those results.

• 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: 10615037
• Report Number: 1061932-2020-00158
• Device Sequence Number: 3806332
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/01/2020

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: 09/08/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1