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

Model Number	AC*T DIFF 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The field service engineer (fse) verified instrument operation with quality control along with repeatability and precision testing.No malfunctions were identified, and the issue could not be reproduced.While onsite, the fse replaced the vacuum isolator chamber (vic) and wbc bath as a preventative measure.The instrument was verified with startup, quality control (qc) and patient samples.All recovered within specification and without error.It is the policy of the clinic to report all results to the physician and then repeat and correct if needed.In the case of the patient that was admitted to the hospital, documentation indicated the sample was repeated later, and the wbc count was 5.8.The corrected result did not get to the physician.A review of subsequent service reports do not show any further contact will beckman coulter for patient or instrument problems.Per act diff 2 instruction for use pn: 4237495 (rev.Bc) section 6.9, ¿if any flag appears, review the results according to your laboratory¿s protocol.Review results.Section 6.4x flag - indicates that one of the multiple aperture alert criteria was not met.1.Thoroughly mix and rerun the sample.2.If flag does not repeat, report result.3.If flag repeats, clean the aperture as instructed in zapping the aperture.4.If after cleaning, problem persists, contact your beckman coulter representative.¿ bec internal identifier (b)(4).
Event or Problem Description
The customer reported patient samples recovered with high wbc results and suspect messaging when cycled on their act diff 2 hematology instrument compared to a rerun on the same instrument.Documentation indicates four erroneous results were reported out of the laboratory since (b)(6) 2023.There was no death, injury or change to patient treatment for three of the patients (patient 1, 2, and 3).There was a change in patient treatment for one patient (patient 4).The patient was admitted to the hospital and given antibiotics due to the erroneous flagged high wbc results reported to the physician.The patient was released from the hospital the next day.Patient sample 1 - printouts received indicated one patient sample (sample 1) recovered with high wbc, hemoglobin (hgb) and hematocrit (hct) results with suspect messaging compared to a rerun on the same instrument the customer believes to be correct.All other cbc parameters correlated between runs.Patient sample 2- printouts also received indicated one patient sample (sample 2) recovered with high wbc and low platelet (plt) results with vote outs for the rbc, hct, mean corpuscular hemoglobin (mch) and mean corpuscular hemoglobin concentration (mchc) parameters compared to a rerun on the same instrument the customer believes to be correct.Patient sample 3- the next printouts received indicated one patient sample (sample 3) recovered with a high wbc result and suspect messaging compared to a rerun on the same instrument the customer believes to be correct.All other cbc parameters correlated between runs.Patient sample 4- the last printouts received indicated one patient sample (sample 4) recovered with a high wbc result and suspect messaging compared to a rerun on the same instrument and a redrawn sample at the hospital the next day following the administering of antibiotics.All other parameters correlated between runs.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16811094
• Report Number: 1061932-2023-00091
• Device Sequence Number: 2920489
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)180126
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AC*T DIFF 2
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown