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	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called to report at least 6 false positive results, later clarified as 10, when running the realtime sars-cov-2 assay.Customer notified abbott that the lab staff is repeating all realtime sars-cov-2 patient samples that generate a positive result with a cycle number (cn) over 28.All sars-cov-2 patient samples reported as positive by the assay are reviewed by lab staff.Any positive sample with cn at 28 or more are repeated on the customer's second m2000 system.The same sample aliquot is used to perform the secondary test.Repeated result is negative.Confirmation testing is done on bdmax and cepheid panels (same aliquot), and the result is negative for all previously positive samples with cn 28 and over.Review by global service and support indicates that log file analysis concluded there is no indication of any system or reagent performance issues.Nine of the ten discrepant results are most likely attributed to the viral concentrations near or below the limit of detection of the assay.Discussion with the customer offered resolution for reporting low-grade positive sars-cov-2 assay results rather than having the samples re-tested.In the future, the customer will include a statement that all positive results with cn greater than 28 cycles are below lod (100 copies/ml), and detected.For the results questioned in this ticket, suspect positive results are not reported outside the laboratory; therefore there is no potential for impact to patient managment.Negative results are reported.
Additional Manufacturer Narrative
The original discrepant result was reported in 3005248192-2020-00081 on (b)(6) 2020.During investigation, 2 additional lot numbers were discovered.The additional lot number will be reported under 3005248192-2022-00165.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 review of the data demonstrated that the assay software and the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 508769, lot 506428 and lot 508421 are performing as expected.The assay reagents performed as expected and met the assay specification requirements without any error codes.There is no indication that lot 508769, lot 506428 and lot 508421 are 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 508769, lot 506428, lot 508421 and their components were performed.The review did not identify any issues which could result in the reported complaint during the production or the release testing for lot 508769, lot 506428 and lot 508421.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 508769, lot 506428, lot 508421 and their components were 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 508769, lot 506428 and lot 508421 identified four additional complaints related to the reported issue.Three complaints were investigated and no product deficiencies were identified.The fourth complaint is currently under investigated.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 508769, lot 506428 and lot 508421 were 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: 13529459
• Report Number: 3005248192-2022-00166
• Device Sequence Number: 17422057
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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: 10/13/2021
• Device Model Number: 09N77-095
• Device Catalogue Number: 09N77-95
• Device Lot Number: 506428
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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