MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT FREE T3; FREE TRIIODOTHYRONINE

Catalog Number 07K63-37

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information, patient identifier: multiple = sid (b)(6).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 impacted lots.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.Correction/removal number = 3005094123-10/22/18-001-c.

Event Description

The customer observed falsely depressed architect free t3 results for 9 patients, while comparing results between 2-point calibrator and 6-point calibrator.The customer noticed that the generated results were inconsistent with tsh/ft4 results.The following data was generated: sid (b)(6): 2.56 (current result), 2.88 (previous result), 2.064 (tsh), and 12.27 (free t4).Sid (b)(6): <2.3 (current result), 2.86 (previous result), 45.216 (tsh), and 5.15 (free t4).Sid 51319763: 2.47 (current result), 3.82 (previous result), 1.67 (tsh), and 17.07 (free t4).Sid (b)(6): 2.43 (current result), 3.58 (previous result), 0.39 (tsh), and 12.64 (free t4).Sid (b)(6): 2.47 (current result), 4.25 (previous result), 1.329 (tsh), and 9.63 (free t4).Sid (b)(6): 2.37 (current result), 3.36 (previous result), 0.385 (tsh), and 11.71 (free t4).Sid (b)(6): 2.55 (current result), 3.23 (previous result), 0.13 (tsh), and 15.67 (free t4).Sid (b)(6): <2.33 (current result), 2.88 (previous result), 0.425 (tsh), and 11.91 (free t4).Sid (b)(6): 2.56 (current result), 4.31 (previous result), 0.232 (tsh), and 12.46 (free t4).There was no reported impact to patient management.

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.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 FREE T3
• Type of Device: FREE TRIIODOTHYRONINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9437758
• MDR Text Key: 219780058
• Report Number: 3005094123-2019-00356
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 00380740144838
• UDI-Public: 00380740144838
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 07K63-37
• Device Lot Number: 02124UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3005094123-10/22/18-001-
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; LIST 03M74-02, SERIAL (B)(6); SERIAL # (B)(6)