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

Model Number	06R8630
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
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.Patient identifier: complete sid's: for 1st patient: (b)(6); 2nd patient sid = (b)(6).
Event or Problem Description
The customer reported a false positive architect sars-cov-2 igg on a (b)(6) yr old asymptomatic white male patient.Results provided: on (b)(6) 2020 sid (b)(6) = 4.13 / 4.09 index (> or = 1.4 index is positive), same sample run on (b)(6) 2020 by hama = 4.03 s/co; new sample on (b)(6) 2020 sid (b)(6) = 4.02 index; on (b)(6) 2020 on beckman access = 0.01 s/co (negative), edi novel coronavirus covid-19 igg elisa = 0.17 od (negative).Additional asymptomatic patient sid (b)(6) = 2.29 / 2.23 index, beckman access = 0.02 s/co (negative), eliza eda = 0.160 o/d (negative).No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely positive results included a search for similar complaints, and the review of complaint text, trending data, labelling, scientific literature and device history records.Return samples were tested and aligned with the results obtained by the customer.Performance testing for reagent lot 16020m800 was completed.Device history record review on lot 16020m800 did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.Performance specificity testing using a retained sample of the complaint lot indicates that the lot is performing acceptably.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: 10202415
• Report Number: 1415939-2020-00062
• Device Sequence Number: 19087677
• Product Code: QKO
• UDI-Device Identifier: 00380740192150
• UDI-Public: 00380740192150
• 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): 07/30/2020

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: 06/04/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR