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	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint has been elevated for investigation.
Event or Problem Description
The customer reported a false positive results on a realtime sars-cov-2 assay.A patient tested positive for sars-cov-2 on the realtime sars-cov-2 assay on (b)(6).A physician questioned the results, so they were retested the following day with a new sample, (b)(6), with negative results.The patient had also tested negative on (b)(6) with a third different sample.All assay parameters, such as assay controls, internal control, reference dye performed as per specifications.The customer was not able to be reached after being contacted three separate times for additional information.There was no report of 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.Customer data review: the review of the customer data demonstrated that the assay software and the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 513138 is performing as expected.The assay reagents performed as expected and met the assay specification requirements without any error codes.There is no indication that lot 513138 is performing outside of established design performance specifications.The result logs for the questioned runs were reviewed.The runs were valid, met assay specification requirements, and no error codes or flags were displayed for the controls.One patient that was tested with different draws (3 times total) called positive result for sars-cov-2 on one out of three runs.Note: on (b)(6) 2021, the customer provided an update.According to the provided update, the cause of the questioned false positive result was determined to be collection error.Quality data review: the device history records (dhr) review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 513138 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 513138.The capa review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 513138 and its components was performed and did not identify any internal or post-production use issues related to the reported complaint.Complaint history review: the lot specific complaint history review for abbott realtime sars-cov-2 amp kit (list 09n77-95) lot 513138 identified one additional complaint ticket related to the reported complaint.This ticket was independently investigated, and no product deficiency was identified.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 513138 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: 11554132
• Report Number: 3005248192-2021-00032
• Device Sequence Number: 19790673
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/07/2021

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: 04/01/2022
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 513138
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1