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	05/15/2020
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 is concerned that when running the realtime sars-cov-2 assay some samples generate a positive result but do not repeat as positive when run on the realtime sars-cov-2 assay, or when re-collected and re-run, or when tested on other platforms such as cdc/state lab, cepheid, or abbott id now.Customer states that some amplification curves look noisy.Customer later communicated that they have reviewed the results internally and no longer have a need to discuss.The customer will continue to use the system.He said that during their internal data review, they compared the various platforms with regard to sensitivity, specificity, and other assay variables.They decided there were too many variables in play to draw conclusions about comparing results from different platforms.The customer then decided to closely monitor the quality parameters of the realtime platform, such as internal control, external controls, and amplification curve profiles.If all of those parameters are in order, they will conclude the result is valid.There has been no report of impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a quality data review and a complaint history review.The results of the investigation are summarized as follows: a customer data review could not be performed as no customer data was provided.Quality data review: as no lot number was provided a device history record review could not be performed.The capa review for abbott realtime sars-cov-2 amp rgt kit (ln 09n77-090) and abbott realtime sars-cov-2 amp rgt kit, us eua (b)(4) was performed and did not identify any internal or post-production use issues related to the reported complaint.Complaint history review: a part-specific complaint history review for abbott realtime sars-cov-2 amp rgt kit (ln 09n77-090) or abbott realtime sars-cov-2 amp rgt kit, us eua (b)(4) identified additional complaint tickets related to discrepant results.However, following the review of the related discrepant result tickets, no commonality was identified which would suggest a product deficiency.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amp rgt kit (ln 09n77-090) or abbott realtime sars-cov-2 amp rgt kit, us eua (b)(4) 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: 10740502
• Report Number: 3005248192-2020-00088
• Device Sequence Number: 3317794
• 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): 07/07/2021

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 Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1