MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 07P48-30

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/17/2023

Event Type  malfunction  

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 Description

The customer observed discrepant alinity i tsh results for a patient sample.The following data was provided (package insert reference range 0.35 to 4.94 uiu/ml): on (b)(6), 2023 sample id: (b)(6), result = 10.0117 uiu/ml, sample discarded and unable to send to other lab for repeat testing.On (b)(6), 2023 sample id: (b)(6), result = 1.8857 uiu/ml, repeat result at another lab on an architect i1000 = 1.71 uiu/ml.On (b)(6), 2023 sample id: (b)(6), result = 5.8177 uiu/ml, repeat result at another lab on an architect i1000 = 5.63 uiu/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for imprecise/discrepant alinity i tsh results 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.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.Ticket and trending review did not identify any trends for the complaint lot.Device history record review did not identify any non-conformances or deviations with the complaint lot and issue.The overall performance of alinity i tsh was reviewed using data gathered from customers worldwide.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.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 48216ud00 was identified.

Event Description

The customer observed discrepant alinity i tsh results for a patient sample.The following data was provided (package insert reference range 0.35 to 4.94 uiu/ml): 17jul2023 sample id (b)(6) result = 10.0117 uiu/ml, sample discarded and unable to send to other lab for repeat testing.18jul2023 sample id (b)(6) result = 1.8857 uiu/ml, repeat result at another lab on an architect i1000 = 1.71 uiu/ml.19jul2023 sample id (b)(6) result = 5.8177 uiu/ml, repeat result at another lab on an architect i1000 = 5.63 uiu/ml.No impact to patient management was reported.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17477313
• MDR Text Key: 320770130
• Report Number: 3005094123-2023-00208
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K983442
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P48-30
• Device Lot Number: 48216UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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, (B)(4) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(4)