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

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	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated tacrolimus (tac) result obtained on a patient sample on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported an erroneously elevated tacrolimus (tac) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The erroneously elevated result was not reported to the physician(s).The same sample was reprocessed on the original dimension® exl¿ 200 integrated chemistry system.A lower result was obtained, considered correct and reported to the physician.There is no known reports of patient intervention or adverse health consequences due to the falsely elevated tacrolimus (tac) result.
Additional Manufacturer Narrative
Additional information (30-aug-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data.No reagent or instrument issues were identified.A high absorbance value was observed for the initial sample, which indicates elevated hemoglobin present.The cause of the event is consistent with the presence of red blood cells (rbc).A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr was filed on 03-jul-2024.

• Brand Name: DIMENSION TACROLIMUS FLEX® REAGENT CARTRIDGE
• Common Device Name: ENZYME IMMUNOASSAY, TACROLIMUS
• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 19667123
• Report Number: 2517506-2024-00178
• Device Sequence Number: 6848084
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: 00842768035425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/24/2024

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: 12/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10700795
• Device Lot Number: GA4361
• 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: 06/16/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2023
• 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