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

Catalog Number 07K63-27

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

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 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 imprecise architect free t3 results for several patients.The customer observed patient results ranging from 2.6 to 10.0 pg/ml and for patient with sid (b)(6), the results observed are 2.23/ 4.16 pg/ml.There has been no adverse impact to patient management reported.

• Brand Name: ARCHITECT FREE T3
• Type of Device: FREE TRIIODOTHYRONINE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8697479
• MDR Text Key: 148072218
• Report Number: 3005094123-2019-00179
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 00380740144814
• UDI-Public: 00380740144814
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Catalogue Number: 07K63-27
• Device Lot Number: 02259UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3005094123-10/22/18-001-
• Patient Sequence Number: 1