MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT SIROLIMUS

Catalog Number	01L76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that patients being treated with everolimus test positive for sirolimus on the architect analyzer.On (b)(6) 2016 a patient being treated with everolimus generated a positive sirolimus result by architect, but a result of <0.9ng/ml on the uplc mass spec.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
The investigation of the customer issue included a review of complaint text, a search for similar complaints, and a review of labeling.The customer observed a falsely elevated sirolimus result, while using architect sirolimus, list 1l76-25 lot 50170m500, on patients being treated with everolimus.A review of complaints for lot 50170m500 did not indicate any similar issue or trend.There was no patient sample available to assist in the investigation.A review of the sirolimus assay product labeling shows adequate information regarding testing and regarding limitations and performance of the assay.The information in the complaint text does not reasonably suggest a malfunction since an everolimus sample was purposely tested on the architect sirolimus assay.Based on the investigation the architect sirolimus reagent, lot 50170m500, is performing as intended and no product issues or malfunctions were identified.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended, and conclusions code was corrected in evaluation codes from (b)(4).

• Brand Name: ARCHITECT SIROLIMUS
• Common Device Name: SIROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 5906437
• Report Number: 1415939-2016-00089
• Device Sequence Number: 421475
• Product Code: NRP
• UDI-Device Identifier: 00380740001346
• UDI-Public: 00380740001346
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K070822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2017

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: 02/03/2017
• Device Catalogue Number: 01L76-25
• Device Lot Number: 50170M500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/04/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/26/2016
• Supplement Report FDA Received Date: 09/16/2016; 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1