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

Catalog Number	DF207 SMN 10700795
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) and reported a falsely depressed tacrolimus (tac) result was obtained on a patient sample on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed tacrolimus (tac) patient result was obtained on a dimension exl 200 system.The falsely depressed result was reported to the physician(s).The same sample was reprocessed on the original dimension exl 200 system.The higher result obtained was considered correct and reported to the physician(s).In a corrected report.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tac result.
Additional Manufacturer Narrative
Additional information (21-apr-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.The customer was utilizing an expired calibrator to perform the calibration.All levels of quality control (qc) values were within the expected reference range however, the values were lower when compared to those values obtained before the calibration with the expired calibrator.Siemens has requested additional information from the customer.The customer has not provided additional information.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00071 was filed with the fda on 16-feb-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: 18719741
• Report Number: 2517506-2024-00071
• Device Sequence Number: 19659779
• 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): 05/08/2024

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: 07/19/2024
• Device Catalogue Number: DF207 SMN 10700795
• Device Lot Number: GA4201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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