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	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased tsh results on one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial=3.41 uiu/ml /repeated=4.60 uiu/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for patient information, patient identifier: sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Complete information for patient information, patient identifier: sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased tsh results on one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial=3.41 uiu/ml /repeated=4.60 uiu/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
Updated d4 device expiration date to 7/18/2022 from 8/18/2022.The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data and in-house testing for architect tsh reagent lot 25030ud00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 25030ud00 was evaluated using world wide data from abbott link.The patient median data were analyzed and compared to an established control limit.All testing meets acceptance criteria for lot 25030ud00 performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect tsh, reagent lot 25030ud00.

• 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
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39E9-32 ; EI N39E932 ; 2246682940
• MDR Report Key: 12778053
• Report Number: 3005094123-2021-00203
• Device Sequence Number: 6120115
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983442
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown