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

Catalog Number 07P45-32

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

The customer observed a false positive alinity i toxo igg result for multiple samples.Results provided: customer provided reference range positive (>1.6 iu/ml) (b)(6) 2022 sid (b)(6) 34-year-old female, initial result = 3.5 iu/ml, repeat result (ai02960) = <0.2 iu/ml (b)(6) 2022 sid (b)(6) 21-year-old female, initial result = 9.70 iu/ml, repeat result (ai02960) = <0.2 iu/ml no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identification: sids (b)(6).Email: (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 7p45-32 that has a similar product distributed in the us, list number 7p45-40/-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.Labeling was reviewed and found to adequately address the issue and provides adequate information regarding the troubleshooting of erratic/discrepant results.Device history record review on lot 44254be00 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.Based on the investigation, no systemic issue or deficiency of the alinity i toxo igg assay for lot number 44254be00 was identified.All available patient information was included.Additional patient details are not available.Corrected data in section h6 - medical device problem code.

• 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: 16111072
• MDR Text Key: 306817312
• Report Number: 3002809144-2022-00453
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/06/2023
• 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)