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

Model Number 06R8620

Device Problem False Negative Result (1225)

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

Event Date 04/30/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative sars-cov-2 igg results generated on the architect i1000sr processing module for one patient.The following data was provided: (b)(6) 2022 initial result generated a negative result of 0.04 s/co, the sample was sent to another laboratory after the physician questioned the result and generated a positive result of >100 (unknown method).The patient was redrawn on (b)(6) 2022 sid (b)(6) and generated a negative result of 0.03 s/co on the architect.The new sample was not retested at another laboratory.No impact to patient management was reported.

Event Description

The customer observed false negative sars-cov-2 igg results generated on the architect (b)(6) processing module for one patient.The following data was provided: (b)(6) 2022 initial result generated a negative result of 0.04 s/co, the sample was sent to another laboratory after the physician questioned the result and generated a positive result of >100 (unknown method).The patient was redrawn on (b)(6)2022 sid (b)(6) and generated a negative result of 0.03 s/co on the architect.The new sample was not retested at another laboratory.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative sars-cov-2 igg results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 35143fn00 and the complaint issue.In-house sensitivity testing was completed with complaint lot number 35143fn00.Testing met acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the sars-cov-2 igg reagent for lot 35143fn00 was identified.

• 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: 14523194
• MDR Text Key: 294497994
• Report Number: 3008344661-2022-00055
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: 35143FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)