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

Model Number	7K62-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
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 has observed falsely decreased architect tsh results with patients with a disorder with clotting called congenital dysfibrinogenemia/ inherited dysfibrinogenemia.Lithium heparin tubes have given normal test results.The customer is aware of package insert instructions, ¿ensure that complete clot formation in serum specimens has taken place prior to centrifugation.Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy may exhibit increased clotting time.If specimens are centrifuged before a complete clot forms, the presence of fibrin or particulate matter may cause erroneous results.¿ the following data was provided: patient 1 serum tsh = 10.7 repeated 0.59.Patient 1 plasma tsh = 10.15 no impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for questionable results for serum samples of tsh with certain tube types in patients with an inherited disorder with clotting called congenital dysfibrinogenemia/ inherited dysfibrinogenemia using architect tsh reagent lot 40382ud00 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Device history record review on lot 40382ud00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.The overall performance of architect tsh reagent lot 40382ud00 reagents in the field was reviewed using data from customers worldwide.Review shows that the median patient results for the complaint lot is within established limits and comparable with historical lots in the field, confirming no systemic issue for the lots.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 40382ud00 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
• 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: 15936269
• Report Number: 3005094123-2022-00285
• Device Sequence Number: 6403783
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/17/2023

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: 11/09/2023
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 40382UD00
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• 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 I2SR REFURB-SEKAT, 03M74-97, ISR02805; ARC I2SR REFURB-SEKAT, 03M74-97, ISR02805
• Patient Sex: Unknown