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	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased alinity i tsh results on multiple patients.The following results were provided: initial results (b)(6) / recollect/redraw results (b)(6): sn# (b)(6) sid (b)(6), male 71 yr initial / retest: 0.110 / 6.99 sn# (b)(6) sid (b)(6), male 62 yr initial / retest: 0.270 / 5.22 sids (b)(6) were both <1.0 on initials tsh reference range: 0.35-4.94 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.All available patient information was included.Additional patient details are not available.Section a1 patient identifier sids: (b)(6).
Event or Problem Description
The customer reported falsely decreased alinity i tsh results on multiple patients.The following results were provided: initial results (b)(6) / recollect/redraw results (b)(6): sn# (b)(6) sid (b)(6), male 71 yr initial / retest: 0.110 / 6.99.Sn# (b)(6) sid (b)(6), male 62 yr initial / retest: 0.270 / 5.22 sids (b)(6) were both <1.0 on initials tsh reference range: 0.35-4.94 uiu/ml.On (b)(6) 2026, the customer reported an additional patient case for falsely decreased alinity i tsh results.The following results were provided: tested on (b)(6) 2026, sid (b)(6), (75-year-old male): units of measure = uiu/ml.Tube 1: initial results on (b)(6): < 1 / 0.127 / 0.172 / 1.475 repeated on (b)(6): 0.216 / 1.647 /4.427.Tested on (b)(6) 2026, sid (b)(6): tube 2 from the same draw time and same patient: initial result on (b)(6): 14.419 / 15.469 (1:5 dilution) repeat result on (b)(6) with a 2nd sample tube = 14.081.Patient¿s previous results were provided: (b)(6): 7.62 / (b)(6) 4.5 / june 69 / (b)(6) 81.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, labeling review, review of the device history record, and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Review of tracking and trending did not identify any trends for lot 76105ud00 and complaint issue.A review of the device history record did not identify any nonconformances, potential nonconformances, or deviations associated with the complaint lot and complaint issue.The overall performance of the alinity i tsh reagents in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.The product labelling provides appropriate information related to the customer issue, which assists them in resolving their issue.Based on the investigation, no systemic issue or product deficiency of the alinity i tsh reagent lot 76105ud00 was identified.Section a patient information: refer to section b5 for complete patient information.Section b5: additional patient data was added.Section d10: concomitant product updated to include alnty i processing modu, 03r65-01, (b)(6).

• 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: 23866126
• Report Number: 3005094123-2025-00658
• Device Sequence Number: 20166159
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)261101(10)76105UD00
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Catalogue Number: 07P48-30
• Device Lot Number: 76105UD00
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown