MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed loci high-sensitivity troponin i (tnih) result was obtained on a patient sample on the dimension exl with lm instrument.The erroneous result was reported to the physician(s) and was questioned.The sample was repeated on an alternate dimension exl with lm instrument.The repeat result recovered higher than the erroneous result, was within the clinical picture and matched the patient¿s history.The repeat result was reported as correct result to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the falsely depressed tnih result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed loci high-sensitivity troponin i (tnih) result was obtained on a patient sample on the dimension exl with lm instrument.Quality control (qc) and calibration were acceptable prior to processing the patient sample.Subsequent tnih qc was reportedly imprecise, which caused the customer to repeat the sample.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, discovered that reagent probe 2 (r2) flush pump syringe malfunctioned, replaced the r2 flush pump syringe, performed r2 flush pump vertical motor diagnostics, replaced the reagent probe 3 (r3) probe, and ran precision tests on patient samples, auto check and qc, which recovered acceptably.The customer performed multiple precision studies using patient samples, which recovered acceptably.Siemens reviewed the instrument data and determined that the malfunctioned r2 flush pump syringe and r3 probe potentially contributed to the falsely depressed tnih result.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19799761
• Report Number: 2517506-2024-00193
• Device Sequence Number: 15302473
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130276
• 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
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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 Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10472176
• 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: 07/05/2024
• Initial Report FDA Received Date: 07/22/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male