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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens remote services center (rsc) and reported that an erroneously depressed creatinine (cre2) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.Calibration was acceptable, and quality control (qc) was within range on the day of the event.Siemens healthineers confirmed a potential for imprecision with dimension cre2 quality control (qc) and patient sample results when using lot numbers ga6307 and ba7005 on the dimension exl 200 integrated chemistry system.The customers were notified through an urgent medical device correction (umdc, letter dc26-01.A.Us) and urgent field safety notice (ufsn, letter dc26-01.A.Ous) titled "imprecision with quality control and patient results for dimension creatinine lot numbers ga6307 and ba7005".The communication was directed to all customers who received dimension creatinine lot numbers ga6307 and ba7005 informing them of the issue and providing instructions the customer must follow.
Event or Problem Description
The customer reported that an erroneously depressed creatinine (cre2) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The erroneous result was reported to the physician(s), who questioned the result.The sample was reprocessed on a non-siemens system.The reprocessed result was higher than the erroneous result and was considered correct.A corrected report was issued by reporting the reprocessed result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed creatinine (cre2) result.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION CREATININE 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: 24743756
• Report Number: 2517506-2026-00059
• Device Sequence Number: 9422396
• Product Code: CGX
• UDI-Device Identifier: 00630414595009
• UDI-Public: (01)00630414595009(10)GA6307(17)261103
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K132638
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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 Model Number: N/A
• Device Catalogue Number: 10872079
• Device Lot Number: GA6307
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-03/25/2026-001-C
• Patient Sequence Number: 1
• Patient Age: 24 MO
• Patient Sex: Female