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	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint has been elevated for investigation.
Event or Problem Description
The customer reported discrepant result of false positive when running the realtime sars-cov-2 assay.Per the customer, the nasopharyngeal sample was collected at a remote location and transported refrigerated.The sample was stored refrigerated in the lab.Customer requested the molecular application specialist (mas) to perform a log review.The mas reviewed amplification curves for the runs in question and determined that first sample on (b)(6) generated a positive result.It was confirmed the initial positive result was reported to the physician and was retested at the physician's request.The same sample was re-run on (b)(6) and the result was negative.Physician was notified of this corrected result.There has been no report of impact to patient management due to this observation.
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.One positive control (cov-2_pos) and one negative control (cov-2_neg) were included in each run.No error codes or flags were displayed for the controls.There is no indication that the abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500 is performing outside of established design performance specifications.Quality data review: the device history record (dhr) review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500 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 abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500 and its components.The capa review was performed to identify any records that were potentially related to the reported complaint for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500 and its components.The review did not identify any internal or post-production use issues related to these lot numbers and the reported issue.Complaint history review: a lot specific complaint review was performed to identify any similar complaints to the ticket being investigated, which reported a discrepant (false positive) result for one patient sample when using abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500.The complaint history review did not identify any additional complaint tickets related to the reported complaint for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 515500.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 515500 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: 12173992
• Report Number: 3005248192-2021-00134
• Device Sequence Number: 1621878
• 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): 09/02/2021

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: 06/09/2022
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 515500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1