MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® CALCIUM FLEX® REAGENT CARTRIDGE

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	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted siemens customer care center (ccc) and reported that abnormal assay flagged calcium (ca) results were obtained on multiple patient samples on a dimension exl with lm integrated chemistry system.Quality control (qc) recovered within the lab ranges on the day of the event.The customer used a new flex of reagent.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument, installed another lot of ca, recalibrated the assay, which recovered acceptably.Then, the customer replaced reagent 1 (r1), and reagent 2 (r2) probes, performed alignments, cleaned windows, reset the result monitor and performed qc, which recovered low but with no abnormal assay flags.Then, the customer recalibrated and processed qc, which recovered acceptably.The cause of the event is unknown.The system is performing according to the specification.No further evaluation is required.
Event or Problem Description
The customer reported that abnormal assay flagged calcium (ca) results were obtained on multiple patient samples on a dimension exl with lm integrated chemistry system.The flagged results were reported to the physician(s).The samples were repeated between an alternate dimension exl with lm integrated chemistry system and atellica analyzer.The repeat results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the abnormal assay flagged ca results.
Additional Manufacturer Narrative
Additional information (30-may-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.The service actions performed by a siemens customer service engineer (cse) mentioned in the initial report did not resolve the issue with abnormal assay flags.Siemens reviewed the standard result monitor abnormal assay technical guidance and noted that the abnormal assay flag is an alert of a potential assay behavior that could potentially result in erroneous but believable results, and persistent abnormal assay flags are most often associated with system water contamination.The customer performed repeat testing as directed in the dimension system operator's guide.Siemens evaluation revealed that the calcium (ca) reagent was performing according to the specifications and when abnormal assay flags were present, there was no effect on the final result.Abnormal assay flagging is not a specification; it is an alert indicating that the analyzer and patient results could be affected, therefore, when results are posted with abnormal assay flags, investigation of the sample is required per the instructions in the dimension system operator's guide.Siemens found that the reagent blank variation in the affected ca reagent lot is typically high, and this variation is not affecting the final results.Based on the unique variation that is present in the affected ca reagent lot, siemens recommended the customer to follow the instructions as provided in the dimension system operator's guide.The device is performing within specifications.No further evaluation is required.Sections h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2025-00006 was filed on 09-jan-2025.Correction: sections d1, d2, d4 have been updated to reflect the calcium (ca) reagent details.Section g1 has been updated to reflect the contact office - manufacturing site details of the calcium (ca) reagent.Section g4 has been updated to reflect the pma/510(k) number of the calcium (ca) reagent.Section h4 has been updated to reflect the device manufacture date for calcium (ca) reagent.Section h8 has been updated to reflect the usage of device for calcium (ca) reagent.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CALCIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21111798
• Report Number: 2517506-2025-00006
• Device Sequence Number: 15636521
• Product Code: CIC
• UDI-Device Identifier: 00842768014123
• UDI-Public: (01)00842768014123(10)BA5273(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K860021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 09/30/2025
• Device Model Number: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: DF23A SMN 10444949
• Device Lot Number: BA5273
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown