MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN, ACT5DIFF AL 100-240V
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	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) stated that upon arrival he found the instrument out of use and reviewed questionable patient samples with extremely high rbc and plt values.Onsite service was performed and the waste syringe assembly and sample syringe were replaced.The fse performed 50 sample cycles with all normal/expected results; the issue could not be reproduced.The fse returned the next day and replaced suspect diluent supply valves vl10 and vl11, and made minor adjustments to the rbc and plt cal factors resolving the reported issue.The specific malfunction and it's resolution could not be confirmed.Bec internal identifier case-(b)(4).
Event or Problem Description
The customer initially reported h&h was not matching for patient samples run on the act5diff al instrument.The customer also stated a grinding noised was observed coming from the instrument.The field service engineer stated that upon arrival he found the instrument out of use and reviewed questionable patient samples with extremely high rbc and plt values.There were a total of four erroneous patient results generated and one result reported outside of the laboratory.There was no report of an adverse event or impact to patient treatment.Instrument data of the erroneous results has not been provided for review, as a result instrument flagging could not be assessed.

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12543816
• Report Number: 1061932-2021-00117
• Device Sequence Number: 4306481
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K032013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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, ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1