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

Catalog Number	07P48-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity thyroid stimulating hormone (tsh) results for one neonatal patient.The results were not reported out as they did not match the patient¿s clinical picture.The sample was very hemolyzed and had particles in it.Another sample was tested and gave the expected results.The following data provided: initial sample tested on (b)(6) 2023, sid (b)(6), tsh result = 0.4042 uiu/ml.Second sample tested on (b)(6) 2023, sid (b)(6), tsh result = 5.15 uiu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = sid (b)(6).
Additional Manufacturer Narrative
The complaint investigation for falsely decreased alinity i tsh results 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.Review of all the information provided by the customer was reviewed.A review of tracking and trending did not identify any related trends for the product for the issue.Device history review did not identify any potential non-conformances, deviations, or non-conformances with the complaint lot.The overall performance of alinity i tsh reagent was reviewed using data gathered from customers worldwide.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 was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i tsh reagent lot 51092ud00 was identified.The following sections have been corrected to reflect the current contact (b)(6), wiesbaden, deu: g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.
Event or Problem Description
The customer observed falsely depressed alinity thyroid stimulating hormone (tsh) results for one neonatal patient.The results were not reported out as they did not match the patient¿s clinical picture.The sample was very hemolyzed and had particles in it.Another sample was tested and gave the expected results.The following data provided: initial sample tested on 02sept2023 sid (b)(6) tsh result = 0.4042 uiu/ml second sample tested on 06sept2023 sid (b)(6) tsh result = 5.15 uiu/ml no impact to patient management was reported.

• Brand Name: ALINITY I 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: 17745985
• Report Number: 3005094123-2023-00243
• Device Sequence Number: 4085484
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/11/2023

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: 08/15/2024
• Device Catalogue Number: 07P48-20
• Device Lot Number: 51092UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown