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	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.
Event or Problem Description
During routine testing of laboratory personnel, one of the lab technician samples generated a positive result on the realtime sars-cov-2 assay.Sample was re-tested with a different platform and with the realtime assay and generated a negative result.Customer is not certain whether the same aliquot was tested in both runs.The customer was concerned that they had to repeat specimens on a different platform.There was also concern that the integrity of some of the specimens deteriorated and gave inconclusive results and that there was days of delay for some specimens.The mas followed up with the customer to clarify whether there was more than one specimen repeated on a different platform along with the patient sample (the lab technician) in question.There were other samples repeated along with the sample in question; there were no other discrepant results detected.The customer clarified that the lab technician's health management was not affected by test results.Customer expressed concern about delays in results reporting as a separate issue, affecting the lab and patient management.There was a delay in result reporting due to an extra time for repeat testing.There is no known affect on patient management due to delay in result reporting.
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 two runs were valid, met all 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 09n77-95) lot 505097 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 505097 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 505097.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 505097 and its components was performed and did not identify any internal or post-production use issues related to these lot numbers.Complaint history review: the lot specific complaint history review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 505097 did not identify any additional complaints.Based on the results of the investigation elements, a product deficiency for the abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 505097 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: 10740865
• Report Number: 3005248192-2020-00089
• Device Sequence Number: 14282270
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 08/06/2021
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 505097
• 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: 04/01/2020
• 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