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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Was this device serviced by a third party? no.3005094123-10/22/18-001-c.Product correction letters were issued on (b)(6) 2018 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.
Event or Problem Description
The customer observed bio-rad quality controls shifted low for total t3 (tt3) while processing on the architect with reagent lot 23219ui00.There was no reported impact to patient management.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11448724
• Report Number: 3005094123-2021-00037
• Device Sequence Number: 19737622
• Product Code: CDP
• UDI-Device Identifier: 00380740014322
• UDI-Public: 00380740014322
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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,Followup
• Report Date (Section B): 05/26/2021

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: 11/10/2021
• Device Model Number: 7K64-25
• Device Catalogue Number: 07K64-25
• Device Lot Number: 23219UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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 I1000SR MOD, 01L86-01, I1SR61554; ARC I1000SR MOD, 01L86-01, I1SR61554