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

Catalog Number	05889057160
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tacrolimus assay on cobas e 411 analyzers (rack system).The sample was initially tested on cobas e 411, serial number: (b)(4), and resulted in a tacrolimus value of 30 ng/ml, accompanied by a data flag.The sample was repeated on cobas e 411, serial number: (b)(4), and resulted in a tacrolimus value of 10.89ng/ml.It is unknown which result was deemed correct.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer checked both analyzers.He replaced parts including the bead mixer motor and tubes.Calibration, quality control, and precision testing were performed; all results were within specifications.Correlation studies were performed and showed similar results.The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2023 was acceptable with no alarms.The investigation determined the service actions performed resolved the issue.

• Brand Name: ELECSYS TACROLIMUS
• Common Device Name: TACROLIMUS ENZYME IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16420595
• Report Number: 1823260-2023-00544
• Device Sequence Number: 15103718
• Product Code: MLM
• UDI-Device Identifier: 04015630947102
• UDI-Public: 04015630947102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173857
• 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): 04/07/2023

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: 01/31/2024
• Device Catalogue Number: 05889057160
• Device Lot Number: 61508801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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