MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant sodium (na) results on multiple patient samples obtained on a dimension exl with lm integrated chemistry system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained discordant sodium (na) results on multiple patient samples on a dimension exl with lm integrated chemistry system.The initial results were not reported to the physician.The same samples were repeated on an alternate dimension exl with lm integrated chemistry system.The repeat results were reported as correct results to the physician.The customer did not provide any patient sample data.There are no known reports of patient intervention or adverse health consequences due to the discordant sodium (na) results.
Additional Manufacturer Narrative
Additional information (05-may-2025): siemens concluded the investigation of the event.Siemens reviewed the instrument data files, and the information provided by the customer.Quality control (qc) and calibrations recovered within customer's acceptable ranges.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse verified the integrated multisensor technology (imt) system, performed a system clean, and ran alignments for all probes.The cse ran a system check and qc, which passed.Siemens concluded that the cause of the event was consistent with the imt fluid flow issue.The event was resolved by performing system cleaning and maintenance.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2025-00067 was filed on 25-apr-2025.Correction: sections d1, d2, d4 have been updated to reflect the instrument details.Section g1 has been updated to reflect the contact office - manufacturing site details of the instrument.Section g4 has been updated to reflect the pma/510(k) number of the instrument.Section h8 has been updated to reflect the usage of device for instrument.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21908594
• Report Number: 2517506-2025-00067
• Device Sequence Number: 19848530
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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
• Report Date (Section B): 05/28/2025

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 Expiration Date: 05/17/2025
• Device Model Number: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: SMN 10472176
• Device Lot Number: 4LD826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown