MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Catalog Number	01L75-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 observed falsely depressed cyclosporine results on the architect i1000sr analyzer.The following data was provided (ng/ml): (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
On (b)(6) 2018, the likely cause was changed from ln 1l75-25 lot 85028m800 manufactured in (b)(4) to the architect i1000sr analyzer ln 01l86-01 sn (b)(4) manufactured in (b)(6).Manufacturer report 1628664-2018-01933 was submitted and will document any follow up information.

• 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: 7877084
• Report Number: 1415939-2018-00129
• Device Sequence Number: 2217580
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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 Catalogue Number: 01L75-25
• Device Lot Number: 85028M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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 I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN (B)(4) ; LN 01L86-01 SN (B)(4)