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

Model Number	E411 RACK
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 688746.The expiration date was requested but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tacrolimus assay results from multiple patient samples tested on the cobas e411 rack.The initial result was not reported outside of the laboratory.The reporter stated that they have an ongoing issue with the tacrolimus assay.They are running the patient samples on both of their e 411 analyzers.Please refer to the attachment pt-83173 in the medwatch for the table containing examples of questionable results and the results reported outside of the laboratory.
Additional Manufacturer Narrative
Medwatch fields d device identification d1-d4 updated.The investigation reviewed the data of the last calibration performed on 22-jun-2023; the signals were within specifications.The investigation reviewed the alarm trace; no issues were noted.The field application specialist (fas) observed the customer's staff technologists pretreating sample procedures; there were no issues noted.The field service representative (fsr) inspected the analyzer and determined that the event was caused by external factors affecting multiple instruments.The customer performed a patient correlation study between their analyzers with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions 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; sandhofer strasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3174767531
• MDR Report Key: 17363151
• Report Number: 1823260-2023-02378
• Device Sequence Number: 17652686
• 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): 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): 09/12/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: E411 RACK
• Device Catalogue Number: 05889057160
• Device Lot Number: 688746
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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