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

Catalog Number 07341920190

Device Problem False Positive Result (1227)

Patient Problems No Consequences Or Impact To Patient (2199); Anxiety (2328); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

A customer from the us alleged on discrepant results for four patient samples when using the cobas® sars-cov-2 & influenza a/b test on the cobas® liat® system (sn (b)(4)).The 4 alleged patient samples generated a positive flu b result in initial testing.Repeat testing on another liat system or on a biofire analyzer generated a negative flu b result.Initial test on (b)(6) 2021 generated a positive result on flu b.Confirmation testing on a boiofire analyzer at another facility generated a negative result for flu b.Initial test on (b)(6) 2021 generated a positive result on flu b.Confirmation testing on a boiofire analyzer at another facility generated a negative result for flu b.Results reported on patients 1 and 2 with a notation that sample would be sent out for confirmation.Initial test on (b)(6) 2021 generated a positive result on flu b.Repeat testing generated negative results on another liat system at the same facility and on another liat system at another facility.The negative result was reported.Initial test on (b)(6) 2021 generated a positive result on flu b.Repeat testing generated negative results on another liat system at the same facility.The sample was re-tested using the biofire analyzer at another facility and a flu b result of "invalid" was obtained and reported.Investigation on the cobas liat system is on-going.Four mdrs, one per each alleged result, will be filed.

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.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 for use on the cobas liat system ((b)(4), product code: qjr).The product catalog number for the test is 09211101190.(b)(4).

Manufacturer Narrative

The customer's cobas® liat® system was returned for evaluation and repair.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 and a new cobas® sars-cov-2 & influenza a/b script to better identify errors and detect abnormal pcr curves will be made available in due course.Consignees have been notified.(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: 11377673
• MDR Text Key: 280445231
• Report Number: 2243471-2021-00386
• Device Sequence Number: 1
• Product Code: OCC
• 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: 04/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1