MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS LIAT SYSTEM; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Catalog Number 07341920190

Device Problems False Positive Result (1227); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problems Anxiety (2328); Unspecified Respiratory Problem (4464); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system (product code: qjr).The product catalog number for the test is 09211101190 and the udi is (b)(4).(b)(4).

Event Description

A customer in the us initially reported the generation of invalid results and one discrepant result when using the cobas liat sars-cov-2/flu test on the cobas liat system.The alleged sample generated a sars-cov-2 not detected, flu a not detected, flu b detected result in the original test.Repeat test generated not detected results for all targets.During the review of the data provided for investigation, it was identified that 2 additional samples had false positive results for sars-cov-2 and flu b.No patient information was provided and no harm was indicated.Three mdrs, one per each alleged result will be submitted.

Manufacturer Narrative

Review of the run data showed the potential false positive results were caused by abnormal baseline/photometer readings.Inspection of the returned cobas liat analyzer found evidence of tube leakage and debris was found on the optical window and at the edges of the window.Additionally, review of the data identified one more run with a potential false positive sars-cov-2 result related to abnormal baseline/photometer readings.As such, one additional mdr will be filed.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 has been launched to better identify the thermal sensor errors.A new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves will be made available in due course.Consignees have been notified.G1 - mfg site information were updated to (b)(4).(b)(4).

• Brand Name: COBAS LIAT SYSTEM
• Type of Device: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 11247389
• MDR Text Key: 230274528
• Report Number: 2243471-2021-00188
• Device Sequence Number: 1
• Product Code: OCC
• UDI-Device Identifier: 07613336100097
• UDI-Public: 07613336100097
• Combination Product (y/n): N
• PMA/PMN Number: K111387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07341920190
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1