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 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Although a root cause cannot be identified, the data shows true amplification for the positive results.No systemic product problem with the reagent or hardware was identified.A result discrepancy may be expected between assays due to potential differences in the tests¿ limit of detection (lod) and intended use.Based on the data analysis review, the product is performing as intended.

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 two patients while using the cobas sars-cov-2 & influenza a/b nucleic acid test on the cobas liat system.The first alleged sample initially generated a positive result for influenza a (negative for influenza b and sars-cov-2).The same sample was retested on the same liat analyzer and generated the same result.The sample was retested on an immunochromatography test and was negative for influenza a.The second alleged sample initially generated a positive result for sars-cov-2 (negative for influenza a/b).The sample was retested on the same liat analyzer and generated a negative result for sars-cov-2 (unknown for influenza a/b).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, 2 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: 18928424
• MDR Text Key: 337963859
• Report Number: 2243471-2024-00799
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 21212F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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