MAUDE Adverse Event Report: BECKMAN COULTER DXI 9000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Lot Number	C11137
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: full patient identifier is (b)(6).A2, a3, a4 and a5: the customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: the access tsh reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman coulter was dispatched to the customer site to evaluate the system.While onsite, fse noted there were too many samples going into the instrument and this patient sample was not prioritized.An investigation is ongoing at this time and no conclusions can be made regarding cause of the event.
Event or Problem Description
On (b)(6) 2024, the customer reported a delay in treatment due to a delay in obtaining a tsh (access tsh, part number: c28643 and lot number not provided) from the customer's dxi (dxi 9000, part number: c11137 and serial number (sn): (b)(6) for one neonatal patient.The customer reported running the patient sample on two of the customer's dxi 9000 instruments (alternate dxi 9000 instrument serial number: (b)(6) and obtaining results from the alternate instrument but not from dxi sn: (b)(6).Customer stated dxi 9000 sn: (b)(6) had displayed a "swt" error for the tsh result.There was no further report of change to patient treatment and no report of injury in connection with this incident.A beckman coulter field service engineer (fse) was onsite at the time of the incident.Fse stated that there were too many samples going onto the dxi 9000 and this sample was not prioritized.An investigation is ongoing at this time.
Additional Manufacturer Narrative
An investigation into the potential cause of the issue is ongoing at this time.
Additional Manufacturer Narrative
A1: full patient identifier is (b)(6).A2, a3, a4 and a5: the customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: a beckman coulter field service engineer (fse) was dispatched.Fse collected information and data which was reviewed by internal instrument team.It was determined that the cause of the event was related to an instrument throughput issue.The instrument does not send an instrument availability status to the laboratory automation system (las) when the sample wheel of the dxi 9000 is getting full and throughput may be affected.It was discussed with the customer the possibility to install an additional instrument to mitigate the throughput constraints.The customer was informed of the investigation.In conclusion, the incident is due to a software limitation around instrument throughput.
Additional Manufacturer Narrative
Added fda tracking number related to (b)(4).

• Brand Name: DXI 9000
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 18945253
• Report Number: 2122870-2024-00013
• Device Sequence Number: 12802222
• Product Code: JJE
• UDI-Device Identifier: 15099590732103
• UDI-Public: (01)15099590732103(11)230316
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K221225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2024

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 Lot Number: C11137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/19/2024; 05/07/2024; 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-05/15/2024-006C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown