MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07P70-77

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The customer reported a falsely increased alinity i free t4 (ft4) result for one patient that was not reported out of the lab.The following results were provided (reference range 9-19.05 pmol/l): sid: (b)(6) on (b)(60 2024- initial results=45 pmol/l; retest results= 18.3 pmol/l there was no impact on patient management reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: sid (b)(6) 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.

Event Description

The customer reported a falsely increased alinity i free t4 (ft4) result for one patient that was not reported out of the lab.The following results were provided (reference range 9-19.05 pmol/l): sid: (b)(6) on 19mar2024- initial results=45 pmol/l; retest results= 18.3 pmol/l.There was no impact on patient management reported.

Manufacturer Narrative

Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 56201ud02, however, in-house performance testing was completed which indicates the product is performing as expected (testing was completed on lot 56201ud00, lot 56201ud00 is a sublot).The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 56201ud02 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot 56201ud02 was identified.

• Brand Name: ALINITY I FREE T4 REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: 19003255
• MDR Text Key: 338982448
• Report Number: 3005094123-2024-00144
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740173715
• UDI-Public: (01)00380740173715(17)240831(10)56201UD02
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P70-77
• Device Lot Number: 56201UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI22575; ALNTY I PROCESSING MODU, 03R65-01, AI22575