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

Catalog Number	07251254190
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys tacrolimus results from the cobas e 801 analytical unit.The initial result was 0.5 ng/ml with a data flag.On (b)(6) 2025, the repeat result was 10.1 ng/ml.On (b)(6) 2025, a new sample was drawn from the patient and the result was 13.0 ng/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration results were within specifications but were in the low range.The qc was within specifications on the date of event.Based on the "sample aspiration alarm" present during sample pipetting, the investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.A general reagent problem was not present, because the qc before the event was within ranges there is no evidence to suggest a malfunction of the device.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21307380
• Report Number: 1823260-2025-00330
• Device Sequence Number: 8903625
• Product Code: MLM
• UDI-Device Identifier: 04015630940271
• UDI-Public: 04015630940271
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/25/2025

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 Catalogue Number: 07251254190
• Device Lot Number: 75323400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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