MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® LOCI HIGH-SENSITIVITY TROPONIN I 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	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed loci high-sensitivity troponin i (tnih) results obtained on two (2) patient samples when reprocessed on a dimension exl 200 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control (qc) recovered within the customer¿s expected ranges, indicating that the tnih assay was performing acceptably.The dimension instructions for use (ifu) for tnih states, "dilute with ctni sample diluent (cat.No.Kd692) to obtain results within reportable range.Enter the dilution factor on the instrument, but no greater than 1:5.Reassay.Resulting readout is corrected for dilution." however, the customer processed the patient samples with a dilution factor greater than 1:5, resulting in the erroneously depressed tnih results.The customer corrected the dilution volume, and the issue was resolved.The cause of the event was consistent with entering the incorrect dilution volume.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed loci high-sensitivity troponin i (tnih) results on two (2) patient samples when reprocessed on a dimension exl 200 system.The initial results obtained using no dilution were considered correct and not reported to the physician(s).Sample identifier (b)(6) was reprocessed using 1:10 dilution, and sample identifier (b)(6) was reprocessed using 1:20 dilution on the original dimension exl 200 system.Lower reprocessed results were obtained and considered erroneously depressed.The erroneously depressed results were reported to the physician(s), and the results were not questioned.Later, sample identifier (b)(6) was reprocessed using 1:8 dilution, and sample identifier (b)(6) was reprocessed using 1:20 dilution on the original dimension exl 200 system.Higher reprocessed results were obtained and considered correct.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed loci high-sensitivity troponin i (tnih) results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® LOCI HIGH-SENSITIVITY TROPONIN I 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21046313
• Report Number: 2517506-2024-00312
• Device Sequence Number: 3417847
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FA5173(17)250622
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K190675
• 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): 12/31/2024

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: 06/22/2025
• Device Model Number: N/A
• Device Catalogue Number: RF627 SMN 10471068
• Device Lot Number: FA5173
• 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: 12/12/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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