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

Catalog Number	07251254190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys tacrolimus results from the cobas e 801 analytical unit that did not match the patient's clinical diagnosis.The initial result was <0.500 ng/ml with a data flag.The repeat result was <0.500 ng/ml with a data flag.On (b)(6) 2024, the sample was repeated with a result of 0.502 ng/ml.
Additional Manufacturer Narrative
Medwatch field b7 was updated.A sample from the patient was tested on a cobas e801 at another site and the results "were consistent".No specific data was provided.The investigation did not identify a product problem.A general reagent issue was excluded.The cause of the event could not be determined as no sample material was available for further investigation.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined as no sample material from the patient was available for further investigation.

• 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: 19119362
• Report Number: 1823260-2024-01181
• Device Sequence Number: 15516047
• Product Code: MLM
• UDI-Device Identifier: 04015630940271
• UDI-Public: 04015630940271
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/15/2024

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: 08/31/2024
• Device Catalogue Number: 07251254190
• Device Lot Number: 668227
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 05/13/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/10/2024; 05/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METHYLPREDNISOLONE; TACROLIMUS
• Patient Sex: Unknown