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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased cyclosporine results while using the architect cyclosprorine assay.The customer provided the following data: patient 1: initial 18.6, retests 84, 66, 243, 194, patient 2: initial 164.4, retests 41, 45, 68, 21, 57, 29.2, patient 3: initial 107.4, retests 217, 60, 343, 36, 70, 21.7, patient 4: initial 4.8, retests 36, 185, 133, 27, 53, 94.8, patient 5: initial 6, retests 99, 82, 25, 43, 230, 126.9, patient 6: initial 49.1, retests 25, 122, 265, 122, 67, 29.6, patient 7: intial 4.5 retests 14.5, 39, 308, patient 8: initial 68.2, retests 101, 263, patient 9: intiial 25.9, retests 85, 223, 323.No 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, and a review of labeling.Return material was not available from the customer.Tracking and trending did not identify an adverse trend for the lot in question.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect cyclosporine reagent, list (b)(4), lot 50164m500, was identified.
Additional Manufacturer Narrative
Correction to the evaluation summary previously documented.The device evaluation was reassessed and concluded that a malfunction occurred.However, no systemic issue or product deficiency 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: 6098692
• Report Number: 1415939-2016-00109
• Device Sequence Number: 974710
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2017

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: 02/04/2017
• Device Catalogue Number: 01L75-25
• Device Lot Number: 50164M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 12/15/2016; 05/11/2017
• 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 (B)(4), SN (B)(4)