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	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased alinity i tsh results for multiple patients that were reported out of the lab.The following results were provided (reference range = 0.7 ¿ 4.17 uiu/ml): (b)(6) 2024 sid (b)(6) initial result=0.01 uiu/ml; (b)(6) 2024 repeated result= 1.61 uiu/ml.(b)(6) 2024 sid (b)(6) initial result=0.01 uiu/ml; (b)(6) 2024 repeated result=1.61 uiu/ml.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 confirm the complaint issue.A search for similar complaints did not identify an increase in complaint activity for lot number 53233ud00.The ticket trending review did not identify any trend regarding commonalties for lot number 53233ud00 and issue.A device history record review did not identify any nonconformances or deviations associated with the lot number 53233ud00 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 53233ud00 is within established limits, indicating that the lot 53233ud00 is performing acceptably in the field.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i tsh lot 53233ud00 was identified.
Event or Problem Description
The customer reported falsely decreased alinity i tsh results for multiple patients that were reported out of the lab.The following results were provided (reference range = 0.7 ¿ 4.17 uiu/ml): on (b)(6) 2024, sid (b)(6), initial result=0.01 uiu/ml; on (b)(6) 2024 repeated result= 1.61 uiu/ml.On (b)(6) 2024 ,sid (b)(6), initial result=0.01 uiu/ml; on (b)(6) 2024 repeated result=1.61 uiu/ml 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: 19177462
• Report Number: 3005094123-2024-00202
• Device Sequence Number: 7402972
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: (01)00380740131142(17)241123(10)53233UD00
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/19/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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); ALNTY I PROCESSING MODU, 03R65-01,(B)(6)
• Patient Sex: Unknown