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	09/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed alinity i tsh for one patient.The following results were provided (reference range 0.32 to 5 mui/l): (b)(6)2024, sid (b)(6), initial tsh result= 2.63 mui/l; unable to repeat due to low sample volume.Historical tsh result (2023)= 5.018 miu/l other samples collected for comparison: (b)(6)2024, sid (b)(6), initial result= 87.35 mui/l, (b)(6)2024, sid(b)(6), initial result= 94.7 mui/l, (b)(6)2024, sid (b)(6), initial result= 62.17 mui/l, (b)(6)2024, sid(b)(6), initial result= 61.65 mui/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
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 without indication for any additional issue.The search for similar complaints for lot 61389ud00 did not identify an increase in complaint activity for the issue.The ticket trending review did not identify any trend regarding commonalties for lot number 61389ud00 and issue.A device history record review did not identify any related nonconformances, potential nonconformances or deviations associated with lot number 61389ud00 and complaint issue.The overall performance of the alinity i tsh was reviewed using field data from customers worldwide.The median population result for the complaint lot are within established limits, indicating that the lot is performing acceptably in the field.Labelling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i tsh reagent lot 61389ud00 was identified.
Event or Problem Description
The customer observed falsely depressed alinity i tsh for one patient.The following results were provided (reference range 0.32 to 5 mui/l): on (b)(6)2024, sid (b)(6), initial tsh result= 2.63 mui/l; unable to repeat due to low sample volume.Historical tsh result (2023) = 5.018 miu/l.Other samples collected for comparison: on (b)(6) 2024, sid (b)(6), initial result= 87.35 mui/l.On (b)(6) 2024, sid (b)(6), initial result= 94.7 mui/l.On (b)(6) 2024, sid (b)(6), initial result= 62.17 mui/l.On (b)(6)2024, sid (b)(6), initial result= 61.65 mui/l.There was no impact to patient management 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: 20332768
• Report Number: 3005094123-2024-00503
• Device Sequence Number: 7979249
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)250808(10)61389UD00
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 08/08/2025
• Device Catalogue Number: 07P48-20
• Device Lot Number: 61389UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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