MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL LOCI HIGH-SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated high-sensitivity troponin i (tnih) patient results obtained on a dimension exl 200.Siemens is investigating the event.
Event or Problem Description
The customer reported erroneously elevated high-sensitivity troponin i (tnih) results on one (1) patient were obtained on a dimension exl 200 system.One of the initial erroneously elevated tnih results obtained on a plasma sample was reported to the physician(s).The other erroneously elevated tnih result obtained on a plasma sample was not reported to the physician(s).Two erroneously elevated tnih results obtained on serum samples from the same patient were obtained for verification purposes only and not reported.A new sample was drawn from the patient and tested on an alternate, non-siemens instrument.Lower tnih results were obtained on the non-siemens instrument and reported to the physician(s) as the correct results.The patient was sent to the emergency room (er) facility after the erroneously elevated tnih results were obtained but was not admitted.The patient was sent home once the correct result was reported.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tnih results.
Additional Manufacturer Narrative
Additional information (19-sep-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data files.Quality control (qc) did recover within the customer¿s acceptable ranges.No reagent nor instrument issues were identified.The cause is consistent with the presence of sample specific interferences in the patient sample.In addition, results between a siemens analyzer and a non-siemens analyzer cannot be directly compared.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00219 was filed on 28-aug-2024.

• Brand Name: DIMENSION EXL LOCI HIGH-SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20081141
• Report Number: 2517506-2024-00219
• Device Sequence Number: 15406462
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FB4350(17)241215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/01/2024

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: 12/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: FB4350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• 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 Age: 86 YR
• Patient Sex: Female