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 False Positive Result (1227); Non Reproducible Results (4029)

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

Event Date 11/17/2021

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 from thailand alleged a discrepant result for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.No harm is alleged.The alleged sample initially generated a positive result for sars-cov-2.The same sample was retested on a different liat analyzer which yielded a negative result for all targets.The same sample was also retested on genexpert and generated a negative result for sars-cov-2.The negative results were reported.An investigation is ongoing to evaluate the customer issue.

Manufacturer Narrative

A supplemental mdr will be submitted to share the conclusions of the investigation.(b)(6).(b)(4).

Manufacturer Narrative

Data was provided and reviewed and it was seen that the alleged run produced a positive sars result.This ct value for the positive run indicates low level of virus present and the curve appears to represent true low-level positive amplification.The data indicated the sample contains a viral target concentration at the limit of detection for the assay, so discrepancies at this level can be expected with repeat testing.The issue is sample specific and no product problem was identified.(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: 12926964
• MDR Text Key: 283671212
• Report Number: 2243471-2021-03839
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10517Y
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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