MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Atellica CH; Atellica CH Tacrolimus

Catalog Number	11097542
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained erroneously depressed tacrolimus (tacr) results on two patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician(s) and were questioned.The samples were repeated on an alternate atellica ch 930 analyzer, and the results recovered higher than the initial results and were considered correct.Corrected reports were issued with the repeat results.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed tacr results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed tacrolimus (tacr) results obtained on two patient samples on an atellica ch 930 analyzer.Calibration and quality control (qc) recovered acceptably on the event date.Siemens is evaluating the event.

• 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 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50771391
• Report Number: 2432235-2026-00222
• Device Sequence Number: 10422501
• Product Code: MLM
• UDI-Device Identifier: 00630414238340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/15/2026

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 Catalogue Number: 11097542
• Device Lot Number: 160057
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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