MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TACROLIMUS; TACROLIMUS IMMUNOASSAY

Catalog Number	07251254190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tacrolimus reagent expiration date was not provided.The cobas e 801 module serial number was (b)(6) the qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 6 patients' samples tested with elecsys tacrolimus assay on a cobas e 801 module.Sample 1: initial result: >40 ug/l.Repeat result: 11.3 ug/l.Sample 2: initial result: >40 ug/l.Repeat result: 10.7 ug/l.Sample 3: initial result: >40 ug/l.Repeat result: 10.1 ug/l.Sample 4: initial result: >40 ug/l.Repeat result: 11.6 ug/l.Sample 5: initial result: >40 ug/l.Repeat result: 12.8 ug/l.Sample 6: initial result: >40 ug/l.Repeat result: 15.7 ug/l.The physician questioned the initial results and requested that the samples be repeated.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The measuring cell was exchanged on (b)(6) 2025.A general reagent issue can be excluded since the qc was within the ranges on the day of the event.The field service engineer performed a liquid flow cleaning.No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event was consistent with a non-optimal customer instrument maintenance.

• Brand Name: ELECSYS TACROLIMUS
• Common Device Name: TACROLIMUS IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23850301
• Report Number: 1823260-2025-05233
• Device Sequence Number: 15906881
• Product Code: MLM
• UDI-Device Identifier: 04015630940271
• UDI-Public: 04015630940271
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/06/2026

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: 07251254190
• Device Lot Number: 83481400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown