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	11/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation is in process.
Event or Problem Description
Customer called to report that 24 samples in one run were called as late positive results on the realtime sars-cov-2 assay, but they were called negative on re-test.Customer indicated that samples are in 2 ml viral transport media.Customer indicates the run in question was performed on (b)(6).The molecular application specialist (mas) reviewed run data to find many of the positive in row h.Mas attempted to ask customer about amplification reagent thawing; however, there was no answer.Mas attempted to follow up with the customer in regards to troubleshooting as well as to understand what results were reported outside the laboratory and if there was any impact to patient management.Responses were not received; below is a chronology of attempts: 18 november mas called lab.Customer not available; mas left a message.19 november mas called to ask customer follow-up questions.Customer indicated that his supervisor would have to answer them.Supervisor was out of the office.Mas agreed to send the list of questions to the customer.Customer agreed to present the questions to his supervisor to address.23 november mas called to follow up with customer.There was no answer.10 december mas called customer.Customer agreed to present the questions to management.There has been no allegation of adverse impact to patient management associated with these questioned results.
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: the results logs for the samples in question were reviewed.It was noted, only 20 samples were identified in the data review, not 24 as originally described by the customer.Runs were valid, met assay specification requirements, and no error codes or flags were displayed for the controls.There is no indication that the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 511194 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 511194 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 511194.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 511194 and its components was performed and did not identify any internal or post-production use issues related to these lot numbers and the reported issue.Complaint history review: the lot specific complaint history review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 511194 did not identify any additional complaints related to the reported issue.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 511194 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: 10988692
• Report Number: 3005248192-2020-00117
• Device Sequence Number: 14322093
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 02/03/2021

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: 02/27/2022
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 511194
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1