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

Model Number	09N78-095
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an additonal false positive result that occurred on (b)(6) 2022 for sample id (sid) (b)(6) on alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032.There was no report of impact to patient management.This event is being reported with the following mdr: 3005248192-2022-01020.
Additional Manufacturer Narrative
This incident is being reported to fda because the incident occurred in taiwan using the alinity m sars-cov-2 assay, list number 09n78-95 which received fda eua approval.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 customer result log files were reviewed.The run which involved the discrepant result was valid and met assay specification requirements.The validity of the run met assay specification requirements, and no error codes or flags were displayed for the run controls.There is no indication that the alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032 is performing outside of established design performance specifications based on the elements reviewed in this section.Quality data review device history record / batch record review: the device history records (dhr) review for alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032 (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.Capa / non-conformance review: the capa review for alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032 (including the components) was performed to identify any records that were potentially related to the reported complaint.The search did not identify any records related to the reported issue for these lot numbers.Complaint history review a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported discrepant results while using alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for alinity m sars-cov-2 amp kit (list 09n78-095) lot 381032 was not identified.

• Brand Name: ALINITY M 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: 16313065
• Report Number: 3005248192-2023-00097
• Device Sequence Number: 17569920
• Product Code: QJR
• UDI-Device Identifier: 00884999049222
• UDI-Public: 00884999049222
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 06/28/2023
• Device Model Number: 09N78-095
• Device Catalogue Number: 9N78-95
• Device Lot Number: 381032
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2022
• 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