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 Problem Device Sensing Problem (2917)

Patient Problems Anxiety (2328); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

The customer alleged discrepant results generated from a cobas® liat® system (s/n (b)(4)).A customer from the united states alleged that they received potential false positive results for patients¿ samples tested with the cobas® sars-cov-2 & influenza a/b (scfa) assay.The customer reported that on (b)(6) 2021 runs # 5897 & 5898 generated sars-cov-2 positive results for 2 patients¿ samples analyzed on the cobas® liat® system (s/n (b)(4)).No patient details were made available, and no harm or injury was indicated.Patients' samples were collected using bd universal transport media.The results were reported out to the patients and/or personnel treating the patients.Two (2) mdrs will be filed one for each sample as per fda guidance.

Manufacturer Narrative

The customer's cobas liat analyzer (s/n (b)(4)) was not requested to be returned for evaluation and repair.From the inspection of data, it was identified that false positive results were identified due to the thermal runaway issue.Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system for one or more targets (sars-cov-2, influenza a, influenza b).When reviewing the customer-provided data associated with the reported invalid and false positive results, abnormal pcr curves were observed.Per the on-going investigation, several potential causes for the abnormal pcr growth curves leading to invalids and false positives have been identified.These include tube leaks, abnormal pcr steps, and loose thermal sensor wiring.Overall across the installed base, these issues from product use may occur sporadically.For invalid or false positive influenza results, adverse health consequences are not likely.For invalid sars-cov-2, adverse health consequences are not likely since detectability is high and testing can be performed on alternative platforms.For erroneous positive sars-cov-2 results, there is the possibility of adverse health consequences in high risk individuals.As stated in the instructions for use, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.A cobas liat software update to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.The implementation of both the software and the updated script have shown a reduction in the calculated false positive rate.Consignees have been notified.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number: 07341920190 and udi: (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test product code qjr, catalog number: 09211101190 and udi: (b)(4).(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
• MDR Report Key: 12685679
• MDR Text Key: 281583575
• Report Number: 2243471-2021-03583
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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: 10628W
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1