MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000RT INSTRUMENT; CLINICAL SAMPLE CONCENTRATOR

Model Number	9K15-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint has been elevated for investigation.
Event or Problem Description
Customer reported that the lamp for their m2000rt instrument was not sitting properly resulting in erroneous results when running the realtime sars cov-2 assay.When running the realtime sars-cov-2 assay, the customer had a few samples which generated positive results but had unexpected graphs.When the customer realized that the graphs looked unnatural, they repeated the samples in another m2000rt instrument, which generated negative results.Customer reported these samples as negative; therefore, suspect results were not released to have any impact to patient management.Other samples run on this run, that did not have enough samples to rerun and confirm were reported as undetermined.Molecular application specialist (mas) performed logfile analysis that revealed the samples had a shaky reference signal which caused the results to be called positive.Mas asked the customer to check the lamp, and customer confirmed that the lamp was not sitting properly.Customer placed the lamp in its position and repeated the calibration.This incident is being reported to fda because the incident occurred in (b)(6) using the m2000rt instrument, 9k15-01, which is registered in the united states, to generate results on the realtime sars cov-2 assay, list number 9n77-90, which is the same/ similar to the realtime sars-cov-2 assay, list number 9n77-95, which received fda eua approval.
Additional Manufacturer Narrative
Investigation into this complaint included a service history review, a complaint history review, a quality data review and a customer data review.The summary of investigation is included below: the service history review for sn (b)(4) found no additional complaint tickets related to the issue under investigation.Complaint history review identified that over the last two years, the complaint investigation currently under review, and eight additional tickets were related to the rt sars-cov-2 amp kit, ln 09n77-90 having lamp noise in the reference dye signal that caused false positive results.Of the eight additional tickets, 3 are still being investigated and five did not identify a product deficiency.Nonconformance (nc) / corrective and preventive action (capa) search identified no nonconformances or capa records related to this issue.Review of available log files revealed that the relative noise values (rnv) are consistent with the observed noise in the reference signal that produced discrepant results.Review of rnvs also indicates that for subsequent runs lamp replacement and optical calibration resolved the noise issue for instrument sn (b)(4).Thus, based on the results of this investigation, no product deficiency was identified for the m2000rt instrument system, ln 09k15-01.

• Brand Name: ABBOTT M2000RT INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 11300518
• Report Number: 3005248192-2021-00012
• Device Sequence Number: 20073470
• Product Code: JJH
• UDI-Device Identifier: 00884999031814
• UDI-Public: 00884999031814
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092705
• 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): 03/23/2021

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
• Operator of Device: No Information
• Device Model Number: 9K15-01
• Device Catalogue Number: 9K15-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1