MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Catalog Number	01L75-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
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.Patient information: no specific patient information was provided.Patient identifier: multiple = (b)(6).
Event or Problem Description
The customer reported falsely elevated architect cyclosporine results.The following initial and repeat results were provided: sample id (b)(6): 171.2, 29.1 and 39.4 ng/dl , sample id (b)(6): 306.7, 77.2 and 79.3 ng/dl.No impact to patient management was provided.
Additional Manufacturer Narrative
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.Tracking and trending report review for the architect cyclosporine assay determined that there were no related trends.An increase in complaint activity was not identified for reagent lot 01011m800.Internal cyclosporine panels were tested using a retained kit of reagent lot 01011m800.Acceptance criteria were met, which indicates acceptable product performance.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect cyclosporine assay was identified.Section d11 concomitant medical products: the serial number was changed from isr52067 to isr52058 refer to related manufacturer report number 1628664-2019-00739 for the device evaluation of the architect i2000sr analyzer.

• Brand Name: ARCHITECT CYCLOSPORINE
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9226536
• Report Number: 1415939-2019-00213
• Device Sequence Number: 13926154
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 01/11/2020
• Device Catalogue Number: 01L75-25
• Device Lot Number: 01011M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(4); SERIAL (B)(4)