MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL T3 REAGENT KIT; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number	7K64-25
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction/removal number: 3005094123-10/22/18-001-c.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 viatmin 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.
Event or Problem Description
The customer observed falsely depressed patient results for total t3 while processing with the reagent lot 13236ui00 on the architect i2000 sr analyzer.No specific patient information was available, but customer stated results were < 0.25, but not discrepance.No impact to patient management was reported.Per the product package insert, the measuring interval limit of quantitation is 1.5 pg/ml and the results were correctly flagged with a less than sign, <.No impact to patient management was reported.

• Brand Name: ARCHITECT TOTAL T3 REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10641642
• Report Number: 3005094123-2020-00223
• Device Sequence Number: 2439535
• Product Code: CDP
• UDI-Device Identifier: 00380740014322
• UDI-Public: 00380740014322
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2021
• Device Model Number: 7K64-25
• Device Catalogue Number: 07K64-25
• Device Lot Number: 13236UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: ARC I2000SR RECONDIT KO, 03M74-65, ISR52315