MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ANTI-TPO REAGENT KIT; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number 09P35-22

Device Problem High Test Results (2457)

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

Event Date 06/19/2023

Event Type  malfunction  

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.

Event Description

The customer observed discrepant alinity i anti-tpo results on two patients.The results provided were: sid (b)(6) initial=15 iu/ml /repeated= <1 iu/ml /repeated=107 iu/ml.Sid (b)(6) initial=6.9 iu/ml /repeated= <1 iu/ml /repeated=24.41 iu/ml.Laboratory reference range for anti-tpo= 0.0 to 5.61 iu/ml there was no reported impact to patient management.

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 in-house testing of alinity i anti-tpo reagent lot number 50321fn00.A review of complaints determined that there are no trends for the product for the complaint issue.A review of tickets determined there is as expected complaint activity for lot number 50321fn00.Return testing was not completed as returns were not available.A performance study testing was performed using a retained kit of lot 50321fn00 and two runs of 18 replicates of anti tpo panels 1-3 were performed on one instrument, therefore 50321fn00 is performing as expected.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity i anti-tpo reagent lot number 50321fn00 was identified.

Event Description

The customer observed discrepant alinity i anti-tpo results on two patients.The results provided were: sid (b)(6) initial=15 iu/ml /repeated= <1 iu/ml /repeated=107 iu/ml.Sid (b)(6) initial=6.9 iu/ml /repeated= <1 iu/ml /repeated=24.41 iu/ml.Laboratory reference range for anti-tpo= 0.0 to 5.61 iu/ml there was no reported impact to patient management.

• Brand Name: ALINITY I ANTI-TPO REAGENT KIT
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17230820
• MDR Text Key: 318198941
• Report Number: 3008344661-2023-00123
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09P35-22
• Device Lot Number: 50321FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI23925; ALNTY I PROCESSING MODU, 03R65-01, AI23925