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

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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneous elevated tacrolimus (tac) patient result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported an erroneous elevated tacrolimus (tac) patient result was obtained on a dimension® exl¿ 200 integrated chemistry system.The erroneous result was reported to the physician, who questioned the result.A different sample was processed on an alternate method 1 (non-siemens method).The alternate method 1 (non-siemens method) result was lower than the erroneous result.The lower result was reported, as the correct result, to the physician.The customer repeated the sample with dilution on the dimension® exl¿ 200 integrated chemistry system and alternate method 1 and another alternate method 2 (non-siemens method) for comparison.The patient had a heart transplant.The tacrolimus medication was delayed.There are no known reports of patient intervention or adverse health consequences due to the delay or erroneous elevated tacrolimus (tac) result.
Additional Manufacturer Narrative
Additional information (15-jan-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s acceptable ranges.Siemens requested the patient samples for further testing.The samples were received by siemens thawed and warm instead of frozen as recommended.The samples could not be tested due to exposure of the samples to temperatures outside of siemens¿ recommendations.The cause of the event is unknown.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 2517506-2024-00231 was filed on 19-sept-2024.

• Brand Name: DIMENSION TACROLIMUS FLEX® REAGENT CARTRIDGE
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• 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: 20260283
• Report Number: 2517506-2024-00231
• Device Sequence Number: 18137439
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: (01)00842768035425(10)GA5133(17)250513
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/28/2025

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: 05/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 10700795
• Device Lot Number: GA5133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 05/31/2024
• 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: 16 YR
• Patient Sex: Female