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	02/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.Lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that realtime sars-cov-2 assay, list number 9n77-90, which is the same/ similar to the realtime sars-cov-2 assay, list number 9n77-95 sold in the united states.Ticket does not reference a us list 9n77-95 lot number.
Event or Problem Description
The customer reported a false positive result on the realtime sars-cov-2 assay.The patient sample was tested twice on the same run.One result was "not detected" and the other result was positive.The customer reported the negative result out of the lab and did not see any further need for repeat testing.There was no report of impact to the patient.This incident is being reported to fda because the incident occurred in macedonia using the realtime sars-cov-2 assay, list number 9n77-90, which is the same/ similar to the realtime sars-cov-2 assay, list number 9n77-95, which received fda eua approval.
Additional Manufacturer Narrative
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 results was valid and met assay specification requirements and no error codes or flags were displayed for the controls.There is no indication that the abbott realtime sars-cov-2 amplification kit (list 09n77-090) lot 512726 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 abbott realtime sars-cov-2 amplification kit (list 09n77-090) lot 512726 (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 abbott realtime sars-cov-2 amplification kit (list 09n77-090) lot 512726 (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 tickets being investigated, which reported discrepant results while using abbott realtime sars-cov-2 amplification kit (list 09n77-090) lot 512726.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for abbott realtime sars-cov-2 amplification kit (list 09n77-090) lot 512726 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 ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 13664929
• Report Number: 3005248192-2022-00303
• Device Sequence Number: 4659775
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• 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): 07/28/2022

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: 09N77-90
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 07/28/2022
• 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