MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH TACROLIMUS

Catalog Number	SMN 11097542
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant tacrolimus (tacr) results obtained on multiple patient samples on an atellica ch 930 analyzer.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) and calibration recovered within the customer¿s expected ranges on the day of the event.The instrument data indicates no issues with the tacrolimus (tacr) assay or the atellica ch 930 analyzer.The customer stated that there was an error in the preparation of the samples during the pre-analytical phase.The cause of the event was consistent with user error.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained discordant tacrolimus (tacr) results on multiple patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician.The same samples were reprocessed on the same atellica ch 930 analyzer.The reprocessed results obtained were considered correct and reported to the physician.The customer declined to provide the patient sample data.There are no known reports of patient intervention or adverse health consequences due to the discordant tacrolimus (tacr) results.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH TACROLIMUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive, po box 6101; newark DE 19714 6101
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21444007
• Report Number: 2432235-2025-00067
• Device Sequence Number: 7724278
• Product Code: MLM
• UDI-Device Identifier: 00630414238340
• UDI-Public: (01)00630414238340(10)140193(17)250214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K060385
• 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
• Report Date (Section B): 02/24/2025

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: 02/14/2025
• Device Catalogue Number: SMN 11097542
• Device Lot Number: 140193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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 Sex: Unknown