MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2 & INFLUENZA A/B; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number 09211101190

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The liat analyzer serial number was (b)(6).Although a root cause cannot be definitively identified, the data showed true amplification for the positive results.A result discrepancy can occur when a sample generates a ct value at the limit of detection (lod) of the assay.Additionally, it is possible that the observed discrepancies that did not generate a ct value at the limit of detection are due to workflow contamination.This is a run/workflow-specific issue and the reagent is performing as expected.

Event Description

In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer alleged a discrepant result for six patient samples while using the cobas sars-cov-2 & influenza a/b nucleic acid test on the cobas liat system.The alleged samples initially generated a positive result for sars-cov-2.Fresh samples from the patients were tested on the same cobas liat analyzer which yielded a negative result for all targets.The initial positive results were not released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 6 mdrs will be filed.

• Brand Name: COBAS® SARS-COV-2 & INFLUENZA A/B
• Type of Device: COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
• 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: 18947999
• MDR Text Key: 339262022
• Report Number: 2243471-2024-00838
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09211101190
• Device Lot Number: 30307Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1