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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.The cobas liat analyzer was requested to be returned for investigation.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 and the udi is (b)(4).(b)(4).

Event Description

A customer from us alleged discrepant result of flu b on 5 different patient samples, with the cobas® sars-cov-2 & influenza a/b test on the cobas® liat® system.The initial samples tested flu b positive and sars-cov-2 & influenza a negative.Repeated testing of the same sample was performed on another cobas® liat® system generated negative results for all 3 targets of sars-cov-2 & influenza a/b assay.To further confirm results were negative the samples were re-tested for a third time on the cepheid® genexpert system and generated negative result for all 3 targets of sars-cov-2 & influenza a/b assay.2 of the positive results were released to patient.No treatment was required and no harm or injury was alleged.Based on the fda guidelines, 5 mdrs will be submitted.

Manufacturer Narrative

Review of the instrument run data revealed there was a tube leak leading to partial obstruction of the optical path and low baseline in the subsequent runs.In addition to the initially alleged 5 samples, there were 4 additional samples produced a false positive result for flu b.Four new mdrs will be filed for the additional samples.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: 11422621
• MDR Text Key: 238357530
• Report Number: 2243471-2021-00461
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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