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 reported falsely depressed architect free t3 (ft3) results on 8 patients compared to the roche method.The results provided were: all 8 initial results =<2.3pmol/l / 3 samples retested = <2.3pmol/l / all 8 samples sent to cerba tested with roche method and all results were within the normal range (3.1-6.8pmol/l).There was no reported impact to patient management.

Manufacturer Narrative

Complete information for section d.Suspect medical device = updated lot number from unknown to 90345ui00, expiration date to 07/01/2019, device manufacturing date to 09/03/2018.Complete information for 3005094123-10/22/18-001-c.

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 FREE T3
• Type of Device: FREE TRIIODOTHYRONINE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8489856
• MDR Text Key: 141178174
• Report Number: 3005094123-2019-00111
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 00380740144814
• UDI-Public: 00380740144814
• 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,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 07K63-27
• Device Lot Number: 90345UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3005094123-10/22/18-001-
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LN 01L86-01; ARCHITECT I1000SR ANALYZER, LN 01L86-01; ARCHITECT I1000SR ANALYZER, LN 01L86-01,; SERIAL # (B)(4). ; SERIAL # (B)(4). ; SERIAL # (B)(4).