MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number	09N77-095
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As lot number is unknown, date of manufacture and expiration date have been left blank.Complaint will be elevated for investigation.
Event or Problem Description
The customer reported 21 false positive results on a realtime sars-cov-2 assay.The customer suspected contamination on their m2000rt instrument, so they retested all 21 samples on an alinity m instrument and received negative results.The positive results were not reported outside the lab, so there was no impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, a quality data review, and a complaint history review.The results of the investigation are summarized as follows: customer data review: a review of the customer result log files was performed.The runs were valid, met all assay specification requirements, and no error codes or flags were displayed for the controls.Note: the complaint issue was concluded by the customer to be a contamination issue.Customer ran saline blanks in the deep well and resulted positive.The false positives issue may have been due to contamination.According to the operations manual, list (9k20-009), version 200681-109 - march 2016.Reusing a deep well plate will result in cross-contamination.To minimize cross-contamination, use a new deep well plate for each run.Quality data review: the device history records (dhr) review for the abbott realtime sars-cov-2 amplification kit, us eua (list 09n77-095) lot 513724 and its components was performed.The review did not identify any issues which could result in the reported complaint during the production or the release testing for lot 513724.No issues related to the reported complaint were reported during quality control testing.Capa / non-conformance review: the capa review was performed to identify any records that were potentially related to the reported complaint for the abbott realtime sars-cov-2 amplification kit, us eua (list 09n77-095) lot 513724 and its complaint components.This capa review did not identify any existing internal issues or post-production use issues related to the reported complaint for the associated lot numbers.Complaint history review: the lot specific complaint history review performed for the abbott realtime sars-cov-2 amplification kit, us eua (list 09n77-095) lot 513724 did not identify any additional complaints related to the reported issue for the realtime sars-cov-2 amplification kit, us eua (list 09n77-095) lot 513724.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit, us eua (list 09n77-095) lot 513724 was not identified.

• Brand Name: ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 11810157
• Report Number: 3005248192-2021-00069
• Device Sequence Number: 3646990
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: No Information
• Device Expiration Date: 04/14/2022
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 513724
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1