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

Model Number 7K62-35

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported false decreased architect tsh results for 7 patients.The following data was provided (customer ran sample undiluted and 1:5 dilution): on (b)(6) 2020; sid: (b)(6) = undiluted = 9.5729 uiu/ml, 1:5 dilution = 12.2937 uiu/ml.On (b)(6) 2020; sid: (b)(6) = undiluted = 4.8958 uiu/ml, 1:5 dilution = 6.6525 uiu/ml.On (b)(6) 2020; sid: (b)(6) = undiluted = 3.6610 uiu/ml, 1:5 dilution = 5.3335 uiu/ml.On (b)(6) 2020; sid: (b)(6) = undiluted = 13.9271 uiu/ml, 1:5 dilution = 25.8510 uiu/ml.On (b)(6) 2020; sid: (b)(6) = undiluted = 9.3810 uiu/ml, 1:5 dilution = 13.3786 uiu/ml.On (b)(6) 2020; sid: (b)(6) = undiluted = 3.5024 uiu/ml, 1:5 dilution = 5.4958 uiu/ml.On (b)(6) 2020; sid (b)(6) = undiluted = 6.7186 uiu/ml, 1:5 dilution = 9.5987 uiu/ml.

Manufacturer Narrative

The complaint investigation for falsely depressed architect tsh results 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.Trending review determined no trends for the issue for the product.Device history record review on lot 11080ui00 did not identify any non-conformances, or deviations.Labeling was reviewed and adequately addressed the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot 11080ui00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect tsh lot number 11080ui00 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: 10656846
• MDR Text Key: 210862197
• Report Number: 3005094123-2020-00225
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 11080UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR54866.; ARC I2K PROC MOD, 03M74-01, ISR54866.