MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07K62-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased architect tsh and provided the following information for 1 patient: on (b)(6) 2024 sample id (b)(6) initial result was 0.4633 uiu/ml and repeat was 0.8393 uiu/ml the customer reported a sample was recollected which generated result of 5.6968 uiu/ml.Additional patient laboratory data: free t4 was 7.2487 pmol/l and repeat results was 6.8814 and 7.3813 pmol/l (package insert reference range is 0.70 ng/dl to 1.48 ng/dl / 9.0104 to 19.0506 pmol/l) upon further review, analyzer log data identified error messages of false 3350 unable to process test, aspiration error for (pipetter) at (sh sample).Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
A1 patient identifier - complete sample id is 380273157sst 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 decreased architect tsh and provided the following information for 1 patient: on 16 mar 2024 sample id (b)(6) initial result was 0.4633 uiu/ml and repeat was 0.8393 uiu/ml the customer reported a sample was recollected which generated result of 5.6968 uiu/ml.Additional patient laboratory data: free t4 was 7.2487 pmol/l and repeat results was 6.8814 and 7.3813 pmol/l (package insert reference range is 0.70 ng/dl to 1.48 ng/dl / 9.0104 to 19.0506 pmol/l) upon further review, analyzer log data identified error messages of false 3350 unable to process test, aspiration error for (pipetter) at (sh sample).Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation 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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Trending review did not identify a related trend regarding commonalities for complaint lot and customer reported event.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the architect tsh reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 59319ud00 are within established limits and thus comparable to the historical lot performance.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent lot 59319ud00 was identified.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19463249
• Report Number: 3005094123-2024-00301
• Device Sequence Number: 20517007
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: (01)00380740014230(17)250520(10)59319UD00
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 08/27/2024

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: 05/20/2025
• Device Catalogue Number: 07K62-25
• Device Lot Number: 59319UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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 I1000SR INTGR, 01L86-40, I1SR60285; ARC I1000SR INTGR, 01L86-40, I1SR60285
• Patient Sex: Unknown