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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) regarding an erroneously elevated human chorionic gonadotropin (hcg) result obtained on a patient sample on a dimension exl with lm integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported that an erroneously elevated human chorionic gonadotropin (hcg) result on a patient sample was obtained on a dimension exl with lm integrated chemistry system.The initial result was not reported to the physician.The same sample was reprocessed on the original dimension exl with lm integrated chemistry system.The reprocessed result recovered lower and was considered correct.Then, the sample was reprocessed on an advia centaur xpt analyzer and atellica im analyzer, which also produced similar lower results and were considered correct.The reprocessed result of 1.45 miu/ml was reported as the correct result to the physician.There is no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
Additional information (17-jul-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the instrument data files, and the information provided by the customer.Calibration was acceptable, and quality control (qc) recovered within the customer's acceptable ranges.The review of instrument data showed that the optics were not good, suggesting a problem with the photometer.These behaviors were observed after sample aspiration for the affected patient sample, suggesting issues with sample delivery.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed a system check for the heterogeneous module (hm), cleaned and aligned the sample probe, wash probes and wash station.Then, the cse verified the probe cleaner functionality and cleaned the sample drain.Siemens concluded that bad sample probe alignments and a dirty sample drain potentially contributed to the reported event.The event was resolved by standard troubleshooting actions performed by the cse.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 2517506-2025-00101 was filed on 18-jun-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 h4 has been updated to reflect device manufacture date 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: 22279890
• Report Number: 2517506-2025-00101
• Device Sequence Number: 14432068
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/08/2025

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: 09/12/2025
• Device Model Number: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: SMN 10472176
• Device Lot Number: FA5255
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2013
• 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: Female