MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION LOCI THYROID STIMULATING HORMONE 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	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that they obtained erroneously depressed loci thyroid stimulating hormone (tshl) results on two (2) patient samples on the dimension exl 200 integrated chemistry system.The customer replaced the active reagent flex with a fresh reagent flex and completed precision studies using low- and high-level controls.Precision results were acceptable and demonstrated consistent assay performance.The customer also performed additional verification testing across multiple assays and obtained expected results, confirming proper analyzer operation and indicating no evidence of an instrument-related issue.The customer further reported that tsh testing has continued to perform normally following replacement of the reagent flex, with precision performance remaining acceptable.Based on the available information and the acceptable precision study results, the most probable cause of the discrepant results was due to the depleted reagent flex.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.
Event or Problem Description
The customer reported that erroneously depressed loci thyroid stimulating hormone (tshl) results were obtained on two (2) patient samples on the dimension exl 200 integrated chemistry system.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on the original dimension exl 200 integrated chemistry system.The repeat result recovered higher than the erroneous results and were reported to the physician(s) as the correct results since they matched the patient¿s clinical history.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed tshl results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION LOCI THYROID STIMULATING HORMONE 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: 25469430
• Report Number: 2517506-2026-00098
• Device Sequence Number: 16028877
• Product Code: JLW
• UDI-Device Identifier: 00842768022081
• UDI-Public: (01)00842768022081(10)EB6343(17)261209
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140842
• 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
• Report Date (Section B): 06/11/2026

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: 10464524
• Device Lot Number: EB6343
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown