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	03/27/2020
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 stated that their run from last week had half the samples generate positive results, which led the customer to suspect contamination as the cause of the issue.Customer was running patient samples.These suspect results were not reported outside of the laboratory and were repeated, therefore, suspect results did not impact patient management.Of 47 repeated samples, 12 come back as true positive.The customer cleaned the instrument, surfaces, and re-tightened all fittings.Customer also performed contamination check and cleaned wells and ran background plate, followed by an environmental run in which all environmental samples came up negative.Customer stated that the instrument and assay have been performing as expected since.
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 relevant data regarding the results of assay controls, calibrators and discrepant patient samples were not 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, 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, 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, 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
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: sarah parker ; 1350 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 10741866
• Report Number: 3005248192-2020-00093
• Device Sequence Number: 19662692
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/04/2022

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
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown