MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
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	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The field service engineer (fse) indicated that controls were ran before and after this event, and they were passing, meeting the published performance specifications.The fse found no malfunction of the instrument.Raw data files (4) were provided for review.Raw data and histogram were reviewed, and no indication of instrument malfunction was revealed.The plt high end (> 20fl) stayed very low and no interference of typical micro rbc or rbc fragment was seen.As the customer claimed that the falsely elevated plt was due to fragmented rbcs, then they must be very small and fall in the interior (2fl-10fl) of the plt histogram region and escaped the detection by the algorithm for interference.Bec internal identifier: (b)(4).
Event or Problem Description
The customer reported erroneously high, unflagged platelet (plt)results for one patient on their unicel dxh 900 coulter cellular analysis system.The patient was a burn victim and the customer stated the high plt result occurred because of the fragmented erythrocyte in the patient sample.The erroneous result was not reported out of the lab, the customer performed a manual smear.The customer indicated that the numeric result from the dxh 900 instrument was 349 x 10^3/ul , however, the results for the manual slide review yielded 217 x 10^3/ul.The count obtained through the manual slide review was the count used for clinical reporting.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: UNICEL DXH 900 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: 11018654
• Report Number: 1061932-2020-00178
• Device Sequence Number: 19786643
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)190715
• 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): 12/16/2020

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 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1