MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Catalog Number	08160104190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).Investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for a single patient sample tested on the cobas® influenza a/b & rsv nucleic acid test for use on the cobas® liat® system.The alleged sample initially generated a positive result on the cobas® liat analyzer.The retested sample generated a negative result on a different instrument.
Additional Manufacturer Narrative
A review of the data showed that the alleged sample initially generated a positive result for the influenza a and rsv targets.The repeat run was performed with a different instrument using the cobas sars-cov-2 & influenza a/b test which generated negative results for all 3 targets.The data review identified 2 more samples generating the same discrepancy.Note, sample 3 was also repeated on the cobas® influenza a/b & rsv assay which generated negative results for all 3 targets.The investigation is complete and revealed that microleaks from positive samples could potentially introduce internal contaminates.The false positive rates observed are within the claims of the ifu.

• Brand Name: COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM
• Common Device Name: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 20569037
• Report Number: 2243471-2024-03134
• Device Sequence Number: 7872585
• Product Code: OCC
• UDI-Device Identifier: 00875197005950
• UDI-Public: 00875197005950
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: Health Professional
• Device Catalogue Number: 08160104190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown