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 03/08/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated alinity i toxo igg result for a patient.The following data was provided (customer¿s reference range: <1.6 iu/ml is non-reactive, 1.6 iu/ml to <3.0 iu/ml is gray zone, >3.0 iu/ml is reactive): (b)(6) 2023 sample id (b)(6) initial result = 8.9 iu/ml, repeat results = 4.7 iu/ml, 3.1 iu/ml, 7.1 iu/ml, 2.3 iu/ml, 2.7 iu/ml, 1.5 iu/ml, 0.9 iu/ml, 2.4 iu/ml, 1.3 iu/ml, 0.3 iu/ml no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.  this report is being filed on an international product, list number 07p45-32 that has a similar product distributed in the us, list number 07p45-45.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity i toxo igg 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 in house testing.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review for lot 46257be00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false reactive results were obtained, indicating that the lot generates the expected results.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity i toxo igg assay for lot number 46257be00 was identified.

• 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: 16532688
• MDR Text Key: 311417484
• Report Number: 3002809144-2023-00120
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: 07P45-32
• Device Lot Number: 46257BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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, (B)(4); ALNTY I PROCESSING MODU, (B)(4)