MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number 7K62-25

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a falsely depressed architect tsh result for a patient when using the architect i1000sr analyzer.The initial tsh result generated a value of 0.0002.The physician questioned this result and recollected a new sample.The new sample was tested and generated a tsh result of 1.8323.The customer repeated the original sample and generated a result of 1.3299.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely depressed architect tsh result included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records and testing of a retained sample of the complaint lot.Return testing was not completed as returns were not available.Trending review determined no trends identified for the issue for the product.Device history record review on lot 25378ud00 did not show any non-conformances, or deviations.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot 25378ud00.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect tsh lot number 25378ud00 was identified.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 12303015
• MDR Text Key: 265878606
• Report Number: 3005094123-2021-00147
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (y/n): N
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: 7K62-25
• Device Catalogue Number: 07K62-25
• Device Lot Number: 25378UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, I1SR52035; ARC I1000SR INTGR, 01L86-40, I1SR52035; ARC I1000SR INTGR, 01L86-40, I1SR52035