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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

The customer observed falsely depressed architect tsh results for one patient that the clinician was questioning.The patient is taking cromoglicate/sawacillin (antibiotics), enteronon (digestive medicine), mucosal (airway lubricant/expectorant), alfrieve rivotril (epilepsy).The following results were provided: (b)(6) 2021, tsh result was (b)(6) / (b)(6) / (b)(6) uiu/ml, ft3(b)(6) pg/ml, ft4 (b)(6) ng/dl; previous results from (b)(6) 2021 were tsh (b)(6) uiu/ml, ft3 (b)(6) pg/ml, ft4 (b)(6) ng/dl, from dec2020 tsh (b)(6) uiu/ml, ft3 (b)(6) pg/ml, ft4 (b)(6) ng/dl.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The ticket search by lots indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review was performed on lot number 30353ud00, which did not show any potential non-conformances, deviations, or non-conformances.Historical performance was evaluated using worldwide field data.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.Labeling review concludes that the issue is adequately addressed.Specimens run on the architect tsh assay must be processed according to the specimen test tube manufacturers¿ instructions.Insufficient processing, including deviations from recommended clotting times, centrifugation times, centrifugation speed and sample preparation techniques, may cause inaccurate results.Based on all reviewed data, we conclude that there is no general issue with the architect tsh reagent lot identified in this complaint.Corrected data found in section g1.Manufacturer contact info.

• 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
• 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 N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13087116
• MDR Text Key: 285395621
• Report Number: 3005094123-2021-00253
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 7K62-25
• Device Catalogue Number: 07K62-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)