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	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation will be performed.
Event or Problem Description
The customer reported that between (b)(6) 2020, there were 94 realtime sars-cov-2 samples identified as possible false positive.94 sars-cov2 patient results were reported as positive.Some of the positive results were questioned by clinicians.All positive samples from runs between (b)(6) 2020 were re-tested on a different platform.Customer used the primary tubes to run confirmatory testing.10 out of 94 previously reported sars-cov2 positive results were confirmed as positive.On(b)(6) 2020, the customer also experienced a failed realtime sars-cov-2 run due to error code 4423, negative control is reactive (ticket (b)(4)).Customer was advised at that time to test environmental samples.Environmental run was set up on (b)(6) 2020: 8 out of 22 tested environmental samples were positive.Customer has been advised to perform laboratory decontamination procedures.The most likely cause of the high number false positive sars-cov-2 patient results is due to environmental contamination in the laboratory.Ambassador assisted with decontamination procedures, and reported that no more contamination was detected.During this contamination issue period, when the negative control would pass the negative specimens would be resulted, and the positive re-tested on another instrument for verification.Suspect results were not reported unless verified.If there was not enough sample to re-test then the result would go out as indeterminate.There has been no report of impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a quality data review and a complaint history review.The results of the investigation are summarized as follows: customer data review: a customer data review could not be performed as relevant data was not provided.The customr reported there was a laboratory contamination issue occurring during the reported date range of the discrepant results and were therefore not reviewed.Quality data review: the device history records (dhr) review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 505380 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 505380.The capa review for abbott realtime sars-cov-2 amplification kit (list 09n77-95) lot 505380 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 505380 did not identify any additional complaints related to the reported 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 505380 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: 10740489
• Report Number: 3005248192-2020-00087
• Device Sequence Number: 3317793
• Product Code: QJR
• UDI-Device Identifier: 00884999049109
• UDI-Public: 00884999049109
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 02/07/2022

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: 10/01/2021
• Device Model Number: 09N77-095
• Device Catalogue Number: 9N77-95
• Device Lot Number: 505380
• 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: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2020
• 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