MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL T3; TOTAL TRIIODOTHYRONINE

Catalog Number	07K64-32
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
Product correction letters were issued on 12oct2018 to all architect total t3 (tt3) and free t3 (ft3) customers, using the i1000sr, i2000, or i2000sr instruments and who received one of the lots listed below.The letter instructed the customers to prevent this interaction by either separating the architect ft3 and/or architect tt3 assays by running these tests on different instruments from the following assays [architect tsh, architect t-uptake, architect hiv ag/ab combo, architect cortisol, architect lh, architect progrp, architect rhtlv-i/ii, architect total psa, architect afp, and architect free psa, architect 25-oh vitamin d], or by performing daily maintenance on the instrument prior to performing batch testing for all ft3 and/or tt3 samples.The mechanism of carryover involves carryover of poly-l-lysine (pll) from other assays into the conjugate dispense step in the ft3 and tt3 assays through adherence of the pipetting probe.Complete information for recall= 3005094123-10/22/18-001-c.
Event or Problem Description
The customer reported an increase in falsely decreased architect total t3 patient results between may and september.The customer received the product correction letter (b)(4)and separated the vitamin d assay from the tt3, but is still seeing low results.There was no reported impact to patient management.
Additional Manufacturer Narrative
Upon further review, the customer's issue is not associated with remedial action (3005094123-10/22/18-001-c ) and is unassigned from the field action.Customers reported that they observed a higher than expected negative bias during their studies.The magnitude of the bias seen was not observed during design verification testing.A review of the internal study including samples across the linear range of the assay, met the established criteria for acceptable bias.Through the review of this complaint, it was identified that the issue is not related to fa12oct2018a, therefore, this complaint is no longer a reportable event.

• Brand Name: ARCHITECT TOTAL T3
• Common Device Name: TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8095347
• Report Number: 3005094123-2018-00168
• Device Sequence Number: 11225231
• Product Code: CDP
• UDI-Device Identifier: 00380740144876
• UDI-Public: 00380740144876
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 01/20/2019
• Device Catalogue Number: 07K64-32
• Device Lot Number: 85165UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005094123-10/22/18-001-
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER, LN 03M74-02; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # ISR50869; SN ISR50869