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

Catalog Number	07P48-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 falsely depressed alinity i tsh results for two patients.The following data was provided: sid (b)(6).Result from (b)(6) 2025 was 0.054 miu/l.Retested (b)(6) 2025 and the result was 18.541 miu/l.Sid (b)(6).Initial result from (b)(6) 2025 was 0.033 miu/l, repeated the sample on the same day and the repeat results were 8.785 and 8.747 miu/l.Customer tsh reference range: 0.35 - 4.94 miu/l.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity i tsh list number 07p48-30, manufacturing site longford, to the alinity i processing module list number 03r65-01, sn (b)(6), manufacturing site irving, tx.Mdr number 3016438761-2025-00401-00 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for two patients.The following data was provided: sid (b)(6) result from (b)(6) 2025 was 0.054 miu/l retested (b)(6) 2025 and the result was 18.541 miu/l.Sid (b)(6) initial result from (b)(6) 2025 was 0.033 miu/l, repeated the sample on the same day and the repeat results were 8.785 and 8.747 miu/l.Customer tsh reference range: 0.35 - 4.94 miu/l.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: 22310427
• Report Number: 3005094123-2025-00317
• Device Sequence Number: 20814461
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)260806(10)73339UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/14/2025

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: 08/06/2026
• Device Catalogue Number: 07P48-30
• Device Lot Number: 73339UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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