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

Catalog Number	07P48-20
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
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 observed a falsely elevated alinity i free t4 results and a falsely depressed alinity i tsh result for one patient.The following data was provided: sid (b)(6), initial free t4 result = 1.69 ng/dl, repeat = 1.26 ng/dl, initial tsh result = 4.31 uiu/ml, repeat = 9.62 uiu/ml & no impact to patient management was reported.
Additional Manufacturer Narrative
Section d4 primary udi number was updated from (b)(4).The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review, and labeling 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.A search for similar complaints did not identify an increase in complaint activity for lot 56154ud00.Trending review did not identify any related trends for the issue for the product.Device history record review did not identify any nonconformances or deviations associated with lot number 56154ud00 and the complaint issue.The overall performance of alinity i tsh was reviewed using field data from customers worldwide.The median population result for lot 56154ud00 is within established limits, indicating that the is performing acceptably in the field.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i tsh for lot 56154ud00 was identified.
Event or Problem Description
The customer observed a falsely elevated alinity i free t4 results and a falsely depressed alinity i tsh result for one sample.The following data was provided: initial free t4 result = 1.69 ng/dl, repeat = 1.26 ng/dl.Initial tsh result = 4.31 uiu/ml, repeat = 9.62 uiu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Section h6 adverse event problem: medical device problem code was corrected from a090809 to a090810.
Event or Problem Description
The customer observed a falsely elevated alinity i free t4 results and a falsely depressed alinity i tsh result for one sample.The following data was provided: initial free t4 result = 1.69 ng/dl, repeat = 1.26 ng/dl initial tsh result = 4.31 uiu/ml, repeat = 9.62 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: 18756960
• Report Number: 3005094123-2024-00068
• Device Sequence Number: 11688212
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)250228(10)56154UD00
• 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,Followup
• Report Date (Section B): 05/02/2024

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: 02/28/2025
• Device Catalogue Number: 07P48-20
• Device Lot Number: 56154UD00
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 05/01/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/01/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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 FREE T4 RGT 200, 07P70-20, 53312UD00; ALNTY I FREE T4 RGT 200, 07P70-20, 53312UD00; ALNTY I FREE T4 RGT 200, 07P70-20, 53312UD00; ALNTY I PROCESSING MODU, 03R65-01, AI01788; ALNTY I PROCESSING MODU, 03R65-01, AI01788; ALNTY I PROCESSING MODU, 03R65-01, AI01788
• Patient Sex: Unknown