MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S CHAGAS REAGENT KIT; TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN

Catalog Number 06P08-45

Device Problem False Positive Result (1227)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up 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 06p08-45, that has a similar product distributed in the us, list number 06p08-50.

Event Description

The customer observed false reactive alinity s chagas results for several patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6) 2021, was 1.010, repeat results were 0.871 and 1.016 s/co.The elisa test result was 0.1, which is nonreactive.Sample id (b)(6) initial result, on (b)(6) 2021, was 1.014, repeat results were 1.010 and 0.931 s/co.The elisa test result was 0.19, which is nonreactive.Sample id (b)(6) initial result, on (b)(6) 2021, was 1.302, repeat results were 1.145 and 1.15 s/co.The elisa test result was 0.19, which is nonreactive.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false reactive alinity s chagas results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Trending review determined no related trend for the issue for the product.A customer data review for alinity s chagas reagent, ln 06p08-45, lot 27171be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at the customer site, whole blood (wb) peer sites and across all customer sites using this lot.The specificity and reactive rate performance of lot 27171be00 at the customer site is within product requirements and comparable to the performance at peer sites.Further, aggregated performance of lot 27171be00 across all customer sites using this lot is within product requirements and comparable to the performance of other lots of the same assay.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s chagas, lot number 27171be00, is performing as intended and no systemic issue or deficiency was identified.Section g1: contact office information updated.

• Brand Name: ALINITY S CHAGAS REAGENT KIT
• Type of Device: TRYPANOSOMA CRUZI (E COLI, RECOMBINANT) ANTIGEN
• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13061460
• MDR Text Key: 282630886
• Report Number: 3002809144-2021-00713
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 03/24/2022

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: 03/08/2022
• Device Catalogue Number: 06P08-45
• Device Lot Number: 27171BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1055; ALNTY S SYSTEM, 06P16-01, AS1055