MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT SIROLIMUS

Catalog Number	01L76-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
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 reported falsely elevated architect sirolimus results for one patient.The customer indicated the undiluted sample (b)(6) generated an initial result of >30 ng/ml and diluted 1:2 generated 9.8 ng/ml.The sample was retested and undiluted generated >30 ng/ml and diluted 1:2 generated 12.83 ng/ml.The customer further reported a second technician setup and ran the sample obtaining an undiluted result of >30 ng/ml and diluted 1:2 generated 33.86 ng/ml.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing, and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the architect sirolimus assay.An increase in complaint activity was not identified for lot 77007m800.A review of the device history record for the likely cause lot did not reveal any issues related to the customer's observation.Accuracy testing was also performed to evaluate the performance of reagent lot 77007m800.An internal sirolimus panel was tested with retained kit of the likely cause reagent lot.Acceptance criteria was met, which indicates acceptable product performance.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or product deficiency of the architect sirolimus assay was identified.

• 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: 7283278
• Report Number: 1415939-2018-00021
• Device Sequence Number: 11261211
• Product Code: NRP
• UDI-Device Identifier: 00380740001346
• UDI-Public: 00380740001346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 12/13/2018
• Device Catalogue Number: 01L76-25
• Device Lot Number: 77007M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/04/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/19/2018
• 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: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4); LIST 03M74-02, SERIAL (B)(4)