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 Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: sid (b)(6).

Event Description

The customer reported falsely decreased architect tsh results for an (b)(6) old male patient while running on the architect i2000sr analyzer.The following data was provided (normal range: 0.35 uiu/ml to 4.94 uiu/ml): on (b)(6) 2020 sid (b)(6).Tsh = 5.14 uiu/ml, repeat = 8.84 uiu/ml.After re-centrifuging: tsh = 5.07 / 7.35 uiu/ml.Sample tested after 2 hours tsh = 10.83 uiu/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely decreased architect tsh results for one patient sample included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Review of ticket searches determined there was normal complaint activity for lot 15460ui00.The trending review determined no trends were identified for the issue for the product.The device history record review on lot 15460ui00 did not show any non-conformances, or deviations.The field data review showed that the median patient result is within established limits, indicating that the lot performs as expected.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 15460ui00 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: 11091445
• MDR Text Key: 238396847
• Report Number: 3005094123-2020-00296
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 7K62-25
• Device Catalogue Number: 07K62-25
• Device Lot Number: 15460UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(4).; ARC I2K PROC MOD, 03M74-01, (B)(4).
• Patient Age: 83 YR