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	04/15/2020
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 reported that when running a realtime sars cov-2 patient specimen the initial test generated a positive result, but on repeat a negative result was generated.Customer wanted to know the cutoff cycle number (cn) for the assay.Molecular application specialist (mas) explained that both the maximum ratio and the cn are used in interpreting results for this assay.Customer said the sample was re-run because the cn was high (31.30).Customer clarified that the sample was rereun because the results showed an internal control flag.He stated he thinks the patient was borderline, and that is why the results were different from each other.The lab asked for a re-collect, but customer does not believe a re-collect was done.No results were reported outside the lab; there was no report of impact to patient management.
Additional Manufacturer Narrative
Lot number was updated after additional information was received.Investigation into this complaint included a customer data review, quality data review, and a complaint history review.The results of the investigation are summarized as follows: customer data review the run was valid, met assay specification requirements, and no error codes or flags were displayed for the controls.Patient sample id (b)(6) tested on (b)(6) 2020 was negative for sars-cov-2.There is no indication that the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504753 is performing outside of established design performance specifications.Quality data review: the device history records (dhr) review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504753 and its components was performed.The review did not identify any issues which could result in the reported complaint during the production or the release testing for lot 504753.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504753 and its components was performed and did not identify any internal or post-production use issues related to these lot numbers and reported issue.Complaint history review: the lot specific complaint history review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504753 did not identify any additional complaint tickets related to this issue.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 504753 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: 10741302
• Report Number: 3005248192-2020-00091
• Device Sequence Number: 3318399
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/08/2022

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: 504753
• 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: 02/08/2022
• 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