MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number	09N77-95
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.
Event or Problem Description
The customer reported false positive results on the realtime sars-cov-2 assay.Customer states there were 10 patient specimens that were high cn positives.They were repeated on the alinity m instrument as negative.The molecular application specialist (mas) reviewed the logs.There was no indication of a carryover event.The customer confirmed there was no impact to patient management as the results were not reported out as positive.
Additional Manufacturer Narrative
D4 - catalog# has been populated.This information was previously provided under model #.G1 has been updated to refelect new personnel.Investigation into this complaint included a customer data review, a quality data review and a complaint history review.Investigation is summarized as follows: customer data review: the customer data review for the reported false positive samples was performed.The runs which involved the discrepant results were valid and met assay specification requirements.There were neither error codes nor flags associated with the assay controls.The amplification curves of the reported discrepant result were analyzed and appeared to have a normal sigmoidal shape.Quality data review: device history record (dhr) / batch record review: the dhr review for abbott realtime sars-cov-2 amplification kit (list 09n77-095) lot 515500 (including the components) was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.No issues were found during quality control (qc) testing.The products passed quality specifications at the time of release.Corrective action preventative action (capa) / non-conformance (nc) review: the capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-095) lot 515500 (including the components) was performed to identify any records that were potentially related to the reported complaint.This capa review did not identify any existing internal issues or post-production use issues related to the reported complaint for the lot numbers under investigation.Complaint history review: a lot specific complaint history review was performed to identify related complaints to the ticket being investigated, which reported false positive results while using abbott realtime sars-cov-2 amplification kit (list 09n77-095) lot 515500.A product deficiency was not identified as a result of this review.Based on the results of the investigation elements, a product deficiency for abbott realtime sars-cov-2 amplification kit (list 09n77-095) 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
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 13391987
• Report Number: 3005248192-2022-00137
• Device Sequence Number: 4114069
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 10/07/2022

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 Expiration Date: 06/09/2022
• Device Model Number: 09N77-95
• Device Catalogue Number: 09N77-95
• Device Lot Number: 515500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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