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	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.As lot number is unknown, date of manufacture and expiration date have been left blank.
Event or Problem Description
Customer reported false positive results were generated when running the realtime sars-cov-2 assay.The false positive results were confirmed on another platform to be negative.The false positive results were not reported to the physician, and did not adversely affect patient management.Molecular application specialist (mas) reviewed data files, had the customer perform a contamination check, and an optical calibration.Mas asked if the customer had bumped into the table or m2000rt instrument.Customer reported, "[they] did not think so." customer reported two successful sars cov-2 runs after optical calibration.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, quality data review, and a complaint history review.The results of the investigation are summarized as follows: customer data review: a customer data review was completed.The run which involved the discrepant result was valid and met assay specification requirements.There were neither error codes nor flags associated with the controls.There is no indication that the abbott realtime sars-cov-2 amplification reagent kit, us eua (list 09n77-095) lot 504903 is performing outside of established design performance specifications.Quality data review: the device history records (dhr) review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504903 (including the components) was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.No issues were found during quality control (qc) testing.The products passed quality specifications at the time of release.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504903 (including the components) was performed to identify any internal or post-production use issues related to the reported complaint and these lot numbers.The search did not identify any records related to the reported issue for these lot numbers.Complaint history review: a lot specific complaint review was performed to identify any similar complaints to the ticket being investigated in 9036-ecinv, which reported discrepant results while using abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504903.The lot specific complaint history review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504903 identified one additional complaint related to discrepant results.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504903 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
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: sarah parker ; 1350 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 10741454
• Report Number: 3005248192-2020-00092
• Device Sequence Number: 3318400
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 02/07/2022

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
• Device Expiration Date: 08/04/2021
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 504903
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2020
• 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
• Patient Sex: Unknown