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

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	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding falsely elevated tacrolimus (tac) results obtained on a patient sample on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
A falsely elevated tacrolimus (tac) result was obtained on a patient sample on a dimension® exl¿ 200 integrated chemistry system.The falsely elevated patient sample result was not reported to the physician.The customer looked back into the records and found on (b)(6) 2024 the patient had a lower tacrolimus (tac) result.On (b)(6) 2024 the same sample was tested on the same dimension® exl¿ 200 integrated chemistry system and did not produce a result but generated an abnormal reaction message.The redrawn sample from (b)(6) 2024 was sent out to a reference lab using liquid chromatography mass spectrometry.A lower result was obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated patient sample result with tacrolimus (tac) result.
Additional Manufacturer Narrative
Additional information (08-july-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.The requested information required to investigate this incident was not made available to siemens.Multiple attempts were made to gather more information to investigate for potential cause but, no response was received from the customer.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 2517506-2024-00149 was filed on 16-may-2024.

• Brand Name: DIMENSION® TACROLIMUS FLEX® REAGENT CARTRIDGE
• Common Device Name: TACROLIMUS ASSAY
• 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: 19332495
• Report Number: 2517506-2024-00149
• Device Sequence Number: 6911027
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: 00842768035425
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 02/11/2025
• Device Model Number: N/A
• Device Catalogue Number: 10700795
• Device Lot Number: GA5042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/30/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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: 72 YR
• Patient Sex: Male