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	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect tsh results for 2 samples when running on the architect i2000sr analyzer.The following data was provided: (b)(6) 2022 sid(b)(6): initial tsh: 2.15uiu/ml, previous result: 4.19 uiu/ml.(b)(6) 2022 sid (b)(6): initial tsh: 0.46 uiu/ml, previous result: 1.09 uiu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient identifier: sid (b)(6) and sid (b)(6) 2 different patients.All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional 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 performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot indicates that the reagent lot performs as expected for the product.A review of tracking and trending determined no related trends identified.Customer field data was used to assess the performance of the architect tsh assay using worldwide data.The median patient population result for lot 32427ud00 is comparable with all other lots in the field and falls within established baselines, confirming no systemic issue for the lot.The device history record was reviewed and did not identify any non-conformances or deviations associated with reagent lot 32427ud00 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect tsh reagent lot 32427ud00 was identified.Section d3 suspect medical device was updated to include new mfg site email section g1 all manufacturers was updated to include new mfg site email.

• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14400449
• Report Number: 3005094123-2022-00103
• Device Sequence Number: 12125396
• 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): 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): 08/24/2022

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: 02/17/2023
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 32427UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2021
• 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
• 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