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 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

Complete information for patient information, patient identifier: sid: (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 07p45-22/32 that has a similar product distributed in the us, list number 7p45-40/45.

Event Description

The customer observed false reactive alinity i (toxoplasmosis) toxo igg results on one patient.The results provided were: on (b)(6) 2023, sid (b)(6), initial=7.1 iu/ml (> or = 3.0 iu/ml=reactive) /repeated on alinity ai21911 =reactive /repeated on alternate method=negative 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 the alinity i toxo igg reagent lot 46257be00.The ticket search determined that there is as expected complaint activity for the likely cause lot.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.A review of 12 months of complaint data did not identify any adverse trends or any non-statistical trends or any atypical complaint activity associated with this described issue.A specificity testing was performed with a retained kit of lot 46257be00.All controls met specifications and no false reactive results were obtained, indicating that the specificity performance is not negatively impacted.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i toxo igg reagent, lot 46257be00.

• 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: 16551832
• MDR Text Key: 311758435
• Report Number: 3002809144-2023-00134
• 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: 03/28/2023

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: 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
• Initial Date Manufacturer Received: 03/11/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6). ; ALNTY I PROCESSING MODU, 03R65-01,(B)(6).