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	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation is in process.Since lot number is not available, expiration and manufacture date have been left blank.
Event or Problem Description
When running the realtime sars-cov-2 assay, customer reported 4 discrepant positive result cases recorded in the period of sept.15 to nov.11.The 4 recorded discrepant result cases were all from internal staff being tested and results were questioned by the in-house physician.There was no known impact on patient management, according to the customer.Sample collection and testing was done within the lab.All four cases were low grade positive on the first run.The second run was done sometime later with a different collection tube.The samples in question were each repeated one to three times.All repeated tests were negative.The molecular application specialist (mas) reviewed available data for runs containing re-test samples.These runs appear as expected, all assay parameters, including ic response, target recovery for the positive samples and controls, background dye is flat with no waviness.The mas reviewed with the customer proper sample handling prior to processing: uncapped sample tubes should be placed into sample racks using great caution to prevent chances of cross-contamination.Since data is not available to look at the runs in question, possible cause of discrepant results may have been sample contamination, instrument noise or other factor(s).According to subsequent and repeat runs, instrument and assay perform per expectations.Customer is satisfied and accepts the instrument for routine use.
Additional Manufacturer Narrative
A specific lot was not implicated in this complaint.Investigation into this complaint included a quality data review and a complaint history review.The results of the investigation are summarized as follows: customer data review: the results logs attached to the ticket did not correspond with the complainant samples listed in the activity of the ticket, data was not available for the runs in question.The ticket states that a molecular application specialist (mas) analyzed the available runs containing re-test samples.No further evaluation could be performed.Quality data review the device history record (dhr) / batch record review could not be performed since the lot number is unknown.The capa review for abbott realtime sars-cov-2 amp rgt kit, us eua (list (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, us eua ((b)(4)) identified several additional complaint tickets related to discrepant results.However, following the review of the related discrepant result tickets, the complaint tickets span across multiple lots and 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, 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: 10992410
• Report Number: 3005248192-2020-00118
• Device Sequence Number: 11632367
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/27/2021

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: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1