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

Model Number	06R8630
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported false negative architect sars-cov-2 igg results on one (b)(6) year old patient while performing correlation studies with biomedomics covid19 igm-igg rapid test.The results generated were being used for individual patient management.The sample was collected at a drive through testing site, therefore, no additional patient information is available.The results provided were: on (b)(6) architect = 0.03s/c (<1.4s/c = negative) / retested = 0.02 and 0.03s/c; biomedomics test shows a strong positive igg band.The sample was also tested on syntron igg / igm and was positive for igg.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.Testing of returned patient sample ((b)(6) with a retained kit of lot 16020m800 gave a negative result and aligned with the results obtained by the customer.In house testing of controls, which mimic patient samples, was completed using a retained kit of lot 16020m800.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the lot and the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation no systemic issue or deficiency of the architect sars-cov-2 igg reagent, lot 16020m800, 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: 10147775
• Report Number: 1415939-2020-00049
• Device Sequence Number: 13976817
• Product Code: QKO
• UDI-Device Identifier: 00380740192150
• UDI-Public: 00380740192150
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 07/22/2020
• Device Model Number: 06R8630
• Device Catalogue Number: 06R86-30
• Device Lot Number: 16020M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR