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	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased alinity i tsh results which questioned by the physician on one 12month old patient.The results provided were: on (b)(6) 2023 sid (b)(6) initial= 0.0875 miu/ml /repeated from /edta sample =0.0820 miu/ml /at reference laboratory=0.0766 and 0.0878 miu/ml.On (b)(6) 2023 redrawn and repeated per physician request sid (b)(6)= 0.8318 miu/ml /same results at reference laboratory laboratory reference range for tsh= 0.35 to 4.94 miu/ml additional information provided: ft3=0.79 ng/ml (reference range=0.35 to 1.93 ng/ml); ft4=10.42 pmol/l (reference range=9 to 19 pmol/l) there was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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 of alinity i tsh reagent lot number 53233ud00.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.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the alinity i tsh reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median population result for the complaint lot(s) are within established limits, indicating that the lot(s) are performing acceptably in the field.Therefore, no unusual reagent lot performance was identified.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i tsh, reagent lot 53233ud00.
Event or Problem Description
The customer observed falsely decreased alinity i tsh results which questioned by the physician on one 12month old patient.The results provided were: on (b)(6)2023 sid (b)(6) initial= 0.0875 miu/ml /repeated from /edta sample =0.0820 miu/ml /at reference laboratory=0.0766 and 0.0878 miu/ml.On (b)(6)2023 redrawn and repeated per physician request sid (b)(6)= 0.8318 miu/ml /same results at reference laboratory laboratory reference range for tsh= 0.35 to 4.94 miu/ml additional information provided: ft3=0.79 ng/ml (reference range=0.35 to 1.93 ng/ml); ft4=10.42 pmol/l (reference range=9 to 19 pmol/l) there was no reported impact to patient management.

• 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: 18284171
• Report Number: 3005094123-2023-00359
• Device Sequence Number: 12429228
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 11/16/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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: 12 MO
• Patient Sex: Unknown