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

Model Number	06R8620
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008344661-2022-00055
• Device Sequence Number: 6635539
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown