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	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.
Event or Problem Description
The customer called to report a patient sample that generated a positive result on the realtime sars-cov-2 assay but generated a negative result when run on the cepheid and diasorin assays.The patient result was reported as positive based on the realtime sars-cov-2 assay result.The customer clarified that the patient result was questioned by the physician since patient was asymptomatic.Patient sample test was then repeated on parallel platforms.Molecular application specialist reviewed logs.Run appears as expected, assay controls, internal and external performed as expected.Further decision about patient medical treatment is not known.There was no report of impact to patient management.
Additional Manufacturer Narrative
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.Per the result log, the patient sample tested on 06/23/2020 was negative for sars-cov-2.There is no indication that the abbott realtime sars-cov-2 amplification regaent kit, us eua (list 09n77-95) lot 506428 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 506428 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 506428.The nonconformance (nc)/corrective action preventative action (capa) review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 506428 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 reagent kit, us eua (list 09n77-95) lot 506428 identified three additional complaints related to the reported issue.Two tickets were investigated and no product deficiencies were identified.The third ticket is currently being investigated.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification reagent kit, us eua (list 09n77-95) lot 506428 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: 10740105
• Report Number: 3005248192-2020-00086
• Device Sequence Number: 19662554
• 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): 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 Expiration Date: 10/13/2021
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 506428
• 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: 02/04/2022
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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