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

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	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated tacrolimus (tac) result on a patient sample on a dimension exl 200 system.No result was obtained on the first run.The same sample was reprocessed on the original dimension vista 500 system and elevated result was obtained.The erroneously elevated result was not reported to the physician(s).The same sample was reprocessed on the original dimension vista 500 system with 1:3 manual dilution and without dilution.The reprocessed results recovered lower, were consistent and considered correct.The reprocessed result of 10.99 ng/ml was reported as correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tacrolimus (tac) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated tacrolimus (tac) result on a patient sample obtained on a dimension exl 200 system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (28-aug-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges.The initial sample exhibited absorbance data with a high value indicating an elevated hemoglobin.The cause of the event is consistent with the presence of red blood cells (rbc) in the initial sample.The issue was resolved by repeating the initial sample with and without dilution, which was part of standard troubleshooting procedures.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2024-00170 was filed on 21-jun-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TACROLIMUS 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19585551
• Report Number: 2517506-2024-00170
• Device Sequence Number: 17017552
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: 00842768035425
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150168
• 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,Followup
• Report Date (Section B): 09/20/2024

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: 12/04/2024
• Device Model Number: N/A
• Device Catalogue Number: DF207 SMN 10700795
• Device Lot Number: GA4339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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