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	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.
Event or Problem Description
Customer reported, for a patient no longer exhibiting symptoms, a clinician questioned a positive result generated on the realtime sars cov-2 assay.Customer reported the clinician questioned the positive result and the sample was retested on another platform using a laboratory developed test (ldt) assay.The ldt assay result was negative.Sample was recollected from the patient and tested on the realtime sars-cov-2 assay.Recollected sample was negative.Original result was amended and reported as a false positive.Patient management was not impacted and patient was not adversely affected.
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 customer run data was valid, met assay specification requirements, and no error codes or flags were displayed for the controls.Quality data review: the device history records (dhr) review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 504783 and its components was performed.The review did not identify any issues which could result in the reported event during the production or the release testing for lot 504783.The capa review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 504783 and its components was performed and did not identify any internal or post-production use issues related to the reported event.Complaint history review: the lot specific complaint history review for abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 504783 identified three (3) additional complaints related to the reported issue.All were independently investigated under and no product deficiencies were identified.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amp rgt kit (list 09n77-95) lot 504783 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: 10741120
• Report Number: 3005248192-2020-00090
• Device Sequence Number: 19662555
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/09/2022

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: 11/21/2020
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 504783
• 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: 02/08/2022
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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