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

Catalog Number 09211101190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 12/06/2021

Event Type  malfunction  

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 discrepant results for a single patient when using the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system.The customer reported that on (b)(6) 2021 the initial test performed with the cobas liat generated sars-cov-2 positive, influenza a negative, and influenza b negative results.The patient sample was recollected and tested.Negative results for all three targets were observed.The initial sample collection was re-tested and generated a flu a positive, flu b negative, and sars-cov-2 negative result.The customer reported all three results but then corrected the results and reported the negative result.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.One mdr will be submitted.

Manufacturer Narrative

An investigation concluded that the ct value generated for the sars positive run indicates that the samples' viral concentration is below the tests limit of detection (lod), note that wavering results may be generated for samples near or below the lod.Regarding the flu a positive result, the amplification is also delayed and after further review of the data it can be seen that three hours earlier a positive flu a result was generated for a different patient sample.It is possible that the sample was contaminated from the previous positive during sample handling.Throughout the data analysis, a systematic issue was not observed and a product problem was not found.(b)(4).

• Brand Name: COBAS® LIAT® 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 13089704
• MDR Text Key: 290697809
• Report Number: 2243471-2021-03924
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10913T
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1