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

Catalog Number	05889057160
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).Qc was performed and it was acceptable.The field service engineer found that the sample probe was misadjusted.He adjusted the sample probe.Precision studies were performed and they were within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's whole blood samples tested with elecsys tacrolimus assay on a cobas e411 immunoassay analyzer.On (b)(6) 2023: initial result: >30 ng/ml.1st repeat result: 9.1 ng/ml.2nd repeat result: 10.2 ng/ml (tested on a different e411).3rd repeat result: 9.7 ng/ml (tested on a different e411).On (b)(6) 2023: initial result: 9.4 ng/ml.1st repeat result: 5.6 ng/ml (new treated sample).2nd repeat result: 6.1 ng/ml (tested on a different e411).The customer noticed that the results did not match the patient's previous results.No erroneous results were reported outside the laboratory and the samples were repeated.All the repeat results were deemed to be correct.The repeat results of 9.1 ng/ml and 5.6 ng/ml were reported outside the laboratory.
Additional Manufacturer Narrative
Calibration signals were within expectations.Upon review of the alarm trace, insufficient sample volume and clot pipetting errors were observed.These are indicators of possible poor sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17850332
• Report Number: 1823260-2023-03143
• Device Sequence Number: 3453533
• Product Code: MLM
• UDI-Device Identifier: 04015630947102
• UDI-Public: 04015630947102
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): Unknown
• 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): 10/13/2023

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 Catalogue Number: 05889057160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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