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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the exact root cause could not be identified, the data showed true amplification for the positive result for flu a target.The investigation indicated that no systemic product problem with the reagent was identified.The discrepancy may be due to sample-specific issues such as collection, handling, and inhibition.Due to inherent differences between technologies, one hundred percent agreement between the results should not be expected as wavering results may occur.No rsv target was detected when the same sample was tested on both cobas liat analyzers.No abnormalities were observed for the curves of that target.Therefore the discrepancy between the cobas liat and abbott platforms is most likely due to technology differences.
Event or Problem Description
A customer from chile alleged discrepant results for a single patient while using the cobas® influenza a/b & rsv nucleic acid test on the cobas® liat® system.The alleged sample initially generated a positive result for influenza a.The same sample was retested on a different cobas liat which generated a negative result for all targets.The same sample was also retested on another platform (abbott) which generated a negative result for influenza a and a positive result for the rsv target.The results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.

• 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 15728471
• Report Number: 2243471-2022-00911
• Device Sequence Number: 7186265
• Product Code: OCC
• UDI-Device Identifier: 00875197005950
• UDI-Public: 00875197005950
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 08160104190
• Device Lot Number: 11108Y
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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