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

Catalog Number 06R86-23

Device Problem False Positive Result (1227)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 06r86-23 (sars-cov-2 igg reagent kit) that has a similar product distributed in the us, list number 06r86-20 /-30 (sars-cov-2 igg assay), eua (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer was conducting a health screening for staff members.Out of the 415 patient samples tested, the customer observed false positive architect sars-cov-2 igg results for 9 samples while running on the architect i2000sr analyzer.The following results were provided (reference range: < 1.4 index is negative, >/= 1.4 index is positive): sid (b)(6): initial result: 1.71 index, repeat results: 0.05, 0.05 index.Sid (b)(6) : initial result: 2.48 index, repeat results: 0.03, 0.03 index.Sid (b)(6): initial result: 1.96 index, repeat results: 0.04, 0.04 index.Sid (b)(6): initial result: 1.58 index, repeat results: 0.77, 0.78 index.Sid (b)(6): initial result: 1.79 index, repeat results: 0.04, 0.03 index.Sid (b)(6): initial result: 1.73 index, repeat results: 0.06, 0.07 index.Sid (b)(6): initial result: 1.62 index, repeat results: 0.05, 0.05 index.Sid (b)(6): initial result: 1.57 index, repeat results: 0.03, 0.03 index.Sid (b)(6): initial result: 1.47 index, repeat results: 0.05, 0.05 index.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false positive architect sars-cov-2 igg results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search by lot indicates that the reagent lot performs as expected for this product.Tracking and trending determined no related trends for the product and for the complaint issue.Clinical specificity and sensitivity testing was performed using an in-house retain kit of lot 33209fn00.All specifications were met indicating the lot is performing acceptably.The device history records were reviewed and did not identify any non-conformances, potential non-conformances, or deviations related to the likely cause lot number or related to the complaint.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 reagent lot 33209fn00 was identified.

• Brand Name: SARS-COV-2-IGG REAGENT KIT
• 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 ; 433331157
• MDR Report Key: 13544409
• MDR Text Key: 286585788
• Report Number: 3008344661-2022-00011
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: 06R86-23
• Device Lot Number: 33209FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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, (B)(6).; ARC I2K PROC MOD, 03M74-01, (B)(6).