MAUDE Adverse Event Report: BECKMAN COULTER DXM 1040 MICROSCAN WALKAWAY; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number	DXM 1040 MICROSCAN WALKAWAY
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	01/17/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The cause of death is unknown.The information available suggests the microscan system failed to identify the organism correctly based on the atypical behavior of the isolate itself and negative lys reaction, which is a key biochemical reaction used by the system to identify an e.Coli.As instrument and panel quality control testing were all in range, a product performance issue or malfunction is not indicated.Panel data did not indicate an obvious instrument or panel issue and confirmed the atypical behavior of the sample.Therefore, the probable cause of the reported organism misidentification was an atypical isolate.Section a4 and a5: information not provided by the customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported getting high probability misidentification (hpid) of citrobacter farmeri on patient samples using neg urine combo 90 (nuc90, p/n c48640, lot # 2025-11-11) panels processed in their dxm 1040 microscan walkaway instrument s/n (b)(6).The customer stated the misidentification impacted one patient sample, multiple cultures.The customer notified the physician of the erroneous results obtained from urine sample.The customer stated the patient was put on hospice and passed away on (b)(6) 2025.It was further noted that the patient did not have capacity and was refusing treatment.The patient¿s family opted for comfort focused measures.The customer indicated they reached out to their internal team, and they stated the misidentification caused a delay in appropriate treatment for the patient.

• Brand Name: DXM 1040 MICROSCAN WALKAWAY
• Common Device Name: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea, california 92821
• Manufacturer (Section G): BECKMAN COULTER INC.; 11800 sw 147th ave.; miami FL 33196
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21381586
• Report Number: 1061932-2025-00018
• Device Sequence Number: 8461603
• Product Code: LRG
• UDI-Device Identifier: 15099590690885
• UDI-Public: (01)15099590690885(11)221025
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K911400
• 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): 02/13/2025

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: DXM 1040 MICROSCAN WALKAWAY
• Device Catalogue Number: B1018-440
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male