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	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed tsh results generated on the alinity i processing module for a 49 year old female patient undergoing dialysis.The following data was provided: on (b)(6) 2023 sample id (b)(6) tsh result = 0.0670 uiu/ml on (b)(6) 2023 same patient, new sample obtained.Sample id (b)(6) tsh result = 0.0673 uiu/ml sample id (b)(6) (same patient as sid (b)(6) tsh result = 0.0647 uiu/ml repeat measurement on (b)(6) (same patient as sid (b)(6) sample id (b)(6) tsh result = 0.0195 uiu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint evaluation 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.The ticket search determined that there is as expected complaint activity for the likely cause lot.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 ticket search by lot indicates that the complaint lot performs as expected for this product.The ticket trending review of at least 12 months complaint data for the likely cause list number did not identify any trend regarding commonalities for lot number and issue.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance 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 and confirms no systemic issue for this lot.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i tsh reagent lot 53233ud00 was identified.
Event or Problem Description
The customer observed falsely depressed tsh results generated on the alinity i processing module for a 49 year old female patient undergoing dialysis.The following data was provided: (b)(6) 2023 sample id (b)(6) tsh result = 0.0670 uiu/ml (b)(6) 2023 same patient, new sample obtained.Sample id (b)(6) tsh result = 0.0673 uiu/ml sample id (b)(6) (same patient as sid (b)(6)) tsh result = 0.0647 uiu/ml repeat measurement on (b)(6) (same patient as sid (b)(6) ) sample id (b)(6) tsh result = 0.0195 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: 18521379
• Report Number: 3005094123-2024-00024
• Device Sequence Number: 15342892
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• 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
• Report Date (Section B): 03/21/2024

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: 11/23/2024
• Device Catalogue Number: 07P48-20
• Device Lot Number: 53233UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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 Age: 49 YR
• Patient Sex: Female