MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I TOXO IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number 07P45-32

Device Problem High Test Results (2457)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Complete information for section 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 false reactive alinity i toxo igg results for two patients processed on the alinity i serial number (b)(4).The samples were ran on another alinity i and results were nonreactive.The following data was provided: processed (b)(6) 2022, (b)(6), initial result = 0.1 iu/ml repeat 3.6 iu/ml.Processed (b)(6) 2022, (b)(6), initial result = 0.2iu/ml repeat 1.9 iu/ml.Reference range = <1.6 iu/ml = negative 1.6 to < 3.0 iu/ml = gray area = 3.0 iu/ml = positive no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive alinity i toxo igg results, using reagent lot number 44254be00, 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.Return testing was not completed as returns were not available.Ticket search by lot indicates that the reagent lot shows slightly higher complaint activity than expected.Ticket review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 44254be00 and the complaint issue.Labeling was reviewed and found to be adequate.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, and no false reactive results were obtained, showing that the lot generates the expected results.Based on our investigation, no systemic issue or deficiency with the alinity i toxo igg reagent for lot 44254be00 was identified.Corrected data in section h4 device mfg date to 09/15/2022 from 05/15/2022.

Event Description

The customer observed false reactive alinity i toxo igg results for two patients processed on the alinity i serial number (b)(6).The samples were ran on another alinity i and results were nonreactive.The following data was provided: processed (b)(6) 2022 sid( b)(6) initial result = 0.1 iu/ml repeat 3.6 iu/ml.Processed (b)(6) 2022 sid (b)(6) initial result = 0.2iu/ml repeat 1.9 iu/ml.Reference range = <1.6 iu/ml = negative 1.6 to < 3.0 iu/ml = gray area = 3.0 iu/ml = positive no impact to patient management was reported.

• Brand Name: ALINITY I TOXO IGG REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16048589
• MDR Text Key: 308472695
• Report Number: 3002809144-2022-00454
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210596
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: 07P45-32
• Device Lot Number: 44254BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)