MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT TACROLIMUS

Catalog Number	01L77-25
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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.
Event or Problem Description
The customer observed one patient with a falsely elevated tacrolimus result while using the architect tacrolimus assay.The following results were provided: the first specimen was collected before 8:00 am: initial result: over 30 ng/ml, retested after dilution: 54 ng/ml.After the patient received tacrolimus a new specimen was tested at 10:30 am, generating a result of 5.38 ng/ml (trough value).The customer indicated that this patient usually has a trough value of 3-4 ng/ml.The specimen was sent to a reference lab and generated similar results (specific results data not provided).No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the customer issue included a review of the complaint text, design history record review, in-house testing, a search for similar complaints, and a review of labeling.Return material was not available from the customer.Returns were not available.The design history record review did not identify any non-conformances, deviations or potential nonconformances of the lot in question.An accuracy testing protocol was executed to evaluate the performance of reagent lot 79026m800; an internal panel was tested with retained kits of the likely cause reagent lot.Testing met the acceptance criteria and determined the reagent is performing acceptably.Tracking and trending did not identify an increase in complaint activity related to falsely elevated results for the lot un question.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect tacrolimus reagent, list 01l77, lot 79026m800, was identified.

• Brand Name: ARCHITECT TACROLIMUS
• Common Device Name: TACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7621698
• Report Number: 1415939-2018-00105
• Device Sequence Number: 11298213
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070820
• 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
• Report Date (Section B): 06/28/2018

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: 03/05/2019
• Device Catalogue Number: 01L77-25
• Device Lot Number: 79026M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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; ARCHITECT I1000SR; LN 01L86, SN (B)(4); LN 01L86, SN (B)(4)