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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: all available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated architect cyclosporine result for a 69 year old male with myasthenia gravis.The sample generated a result of approximately 400 and retest generated 200.The customer indicated the patient's results prior to last month were less than 30.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity did not identify any adverse or non-statistical trends for the architect cyclosporine assay.An increase in complaint activity was not identified for reagent lot 88026m800.Accuracy testing was also performed to evaluate the performance of reagent lot 88026m800.An internal panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria was met, which indicates acceptable product performance.Manufacturing documentation for the likely cause 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.

• 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: 8474436
• Report Number: 1415939-2019-00020
• Device Sequence Number: 1846835
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/18/2019

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: 06/07/2019
• Device Catalogue Number: 01L75-25
• Device Lot Number: 88026M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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 ANALYZER, LN 03M74-01; ARCHITECT I2000SR ANALYZER, LN 03M74-01; SERIAL (B)(4); SERIAL (B)(4); ARCHITECT I2000SR ANALYZER, LN 03M74-01; SERIAL(B)(4)
• Patient Age: 69 YR