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

Catalog Number 06S60-22

Device Problem False Negative Result (1225)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06s60-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20/-30 (advisedx sars-cov-2 igg ii), (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative architect sars-cov-2 igg ii quant result for a patient with a covid vaccination history.The following results were provided (reference range: < 50 au/ml is negative, >/= 50 auml is positive): sid (b)(6): 1st result at 12:40 pm = < 6.8 au/ml (negative), 2nd result at 23:05 pm = 35382.4 au/ml (positive), 3rd result at 23:51 pm = 37460.7 au/ml (positive) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely negative architect sars-cov-2 igg ii quant.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.The lot search review did not identify an increase in complaint activity for the issue.Trending was reviewed and determined no trends were identified for the product for the issue.Clinical specificity and sensitivity testing was performed using an in-house retained kit of complaint lot 30412fn00.All specifications were met indicating the lot is performing acceptably.Device history record was reviewed and did not identify any non-conformances or deviations associated with the lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.In this case, discrepant results were obtained however review of the pressure monitoring (pm) log file indicates potential issues with the pm of the sample when the negative result was obtained.In addition, the customer retested the sample in duplicate with the same reagent lot and obtained expected results indicating the reagent is performing acceptably.Based on the investigation, no systemic issue or product deficiency for architect sars-cov-2 igg ii quant.Reagent lot 30412fn00 was identified.G1 all manufacturers: g1 - contact information has been updated to included new contact name, email, address, phone number, and fax number.

• Brand Name: SARS-COV-2 IGG II QUANT 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13044084
• MDR Text Key: 283257814
• Report Number: 3008344661-2021-00215
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2021
• Device Catalogue Number: 06S60-22
• Device Lot Number: 30412FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR53223; ARC I2000SR INST, 03M74-02, ISR53223