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

Model Number	7K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely depressed architect tsh, architect free t4 (ft4), architect total t4 (t4), architect total t3 (t3) results for a (b)(6) female patient.The following thyroid profile data was provided (customer expected values: tsh = 0.35-4.94 uiu/ml, t4 = 4.87-11.72 ug/dl, t3 = 0.58-1.59 ug/ml, ft4 = 0.70-1.48 ng/dl): on (b)(6) 2021, id 11790862 = initial thyroid profile results: tsh = 0.93 uiu/ml, t4 = 4.07 ug/dl, t3 = 0.53 ng/ml, ft4 = 0.80 ng/dl.A new patient sample was tested and gave the following results: tsh = 2.08 iu/ml, t4 = 8.54 ug/dl, t3 = 0.96 ng/dl, ft4 = no result given.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect tsh results included a search for similar complaints, and the review of complaint text and attached data, trending data, labeling, and device history records.Return testing was not completed as returns were not available.In-house testing for reagent lot 25030ud00 was completed.Trending review determined no trends identified for the issue for the product.Device history record review on lot 25030ud00 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 25030ud00.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 reagent lot number 25030ud00 was identified.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 12191752
• Report Number: 3005094123-2021-00135
• Device Sequence Number: 3036003
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 07/18/2022
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 25030UD00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR55345; ARC I2000SR INST, 03M74-02, ISR55345
• Patient Age: 69 YR