MAUDE Adverse Event Report: ABBOTT LABORATORIES SARS-COV-2 IGG

Model Number	06R8620
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
A physician reported false negative architect sars-cov-2 igg results on one patient via (b)(6) post, therefore, no additional patient information is currently available.The results provided: (b)(6) lab sars coronavirus 2 rna by pcr result =positive after 13 days of symptoms, sample collected (b)(6) 2020 / architect sars-cov-2 igg result=negative after 55 days from symptom onset.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for falsely negative results included a search for similar complaints, and the review of complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.In-house testing for reagent lot 15014m800 was completed and showed that the assay performs acceptably.Device history record review of lot 15014m800 did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect sars-cov-2 igg reagent lot 15014m800 was identified.

• Brand Name: SARS-COV-2 IGG
• Common Device Name: COV-2 IGG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10110970
• Report Number: 1415939-2020-00041
• Device Sequence Number: 11614616
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 10/03/2020
• Device Model Number: 06R8620
• Device Catalogue Number: 6R86-20
• Device Lot Number: 15014M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1