MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
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	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per information provided by the sas, no service request was created for this event, because the customer indicated that this is a sample related issue.This is an event associated to the unique cytopathology of this patient with mds.Provided raw data and histogram information were reviewed.The available information does not reveal the root cause of the failure.Raw data was not able to confirm conclusively an assignable cause.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported that their unicel dxh 800 coulter cellular analysis system generated erroneous high platelet (pl:t) counts, without any flags, for a single patient with myelodysplastic syndromes (mds).The customer reported that the instrument did not flag the platelet results that had been flagged low by the reference interval.A manual count was done by the customer and indicated that the platelet count was even lower.The customer indicated that counts were considered erroneously high, in comparison to the count expected for the clinical condition of this patient.The senior applications scientist (sas) for this customer indicated that the doctor at this institution was aware of the condition of the patient (myelodysplastic syndromes (mds)).Patient data provided shows that the instrument flagged for reference (user defined) limits (l) for platelets, and triggered a suspect message for the presence of abnormal ret in the sample, indicating the operator that the results had to be reviewed according to their laboratory¿s protocol.The customer stated that the suspect results were not reported out of the lab.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 8746451
• Report Number: 1061932-2019-01687
• Device Sequence Number: 19426109
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140911
• 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): 06/28/2019

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 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1