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 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i toxo igg reagent lot #: 35560be00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Clinical specificity of the alinity i toxo igg assay has been evaluated with a retained in-house kit of the same lot #: 35560be00 and met all specifications confirming that this lot is meeting the alinity i toxo igg product requirements.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the alinity i toxo igg kit (lot #: 35560be00).Patient identifier complete sid: (b)(6).This report is being filed on an international product list number: 7p45-32 that has a similar product distributed in the us, list number: 7p45-45.

Event Description

The customer observed a false reactive alinity i toxo igg result, which was reported to be inconsistent with the patients history and questioned by the patients physician.The customer provided the following data: on (b)(6) 2022 result was < 0.20 iu/ml (non-reactive), on (b)(6) 2022 result was 17.60 iu/ml (reactive) (sample id provided: (b)(6)), on (b)(6) 2022 result was < 0.20 iu/ml (non-reactive).There was no reported impact to patient management.

• 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: 16021652
• MDR Text Key: 308534550
• Report Number: 3002809144-2022-00450
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 12/21/2022

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: 11/16/2022
• Device Catalogue Number: 07P45-32
• Device Lot Number: 35560BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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, AI02377.