MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2-IGG ASSAY; REAGENT, CORONAVIRUS SEROLOGICAL

Model Number 06R8620

Device Problem False Positive Result (1227)

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

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

In a literature article by joseph simonson, et al., ¿the clinical impact of the covid 19 pandemic first wave on patients with cystic fibrosis in new york¿, a retrospective cohort study including people with cystic fibrosis in new york from march 1, 2020 to august 31, 2020 at 12 adult and pediatric cystic fibrosis centers.The abbott architect (cmia method) reported one false positive architect sars-cov2 igg in a sample of 1020 specimens.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a false positive architect sars-cov-2 igg result included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records, and in-house testing.Return testing was not performed as returns were not available.A review of tracking and trending did not identify any related trends.A complaint review did not identify an increase in complaint activity for false positive results.The device history record was reviewed and did not show any related potential non-conformances, deviations, or non-conformances associated with the complaint list number and issue.To further investigate the issue, as the lot number is unknown, a representative in-house retain file lot was used for clinical specificity testing.Performance testing was performed using in-house retain file kit for lot 40132fn00.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect sars-cov-2 igg assay was identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• Brand Name: SARS-COV-2-IGG ASSAY
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15229374
• MDR Text Key: 301268429
• Report Number: 3008344661-2022-00092
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, 116UNKNOWN.; ARC I2K PROC MOD, 03M74-01, 116UNKNOWN.