MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 09211101190

Device Problem False Positive Result (1227)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

The analyzer was returned.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.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).

Event Description

A customer in the united states returned a cobas liat analyzer.The data was reviewed and it was found that 13 false positive (one sars-cov-2, one sars-cov-2, flu a, flu b and 11 flu b) results were generated while using cobas sars-cov-2 & influenza a/b test for use on the cobas liat system (lot 10304x, expiration date 28february2022; serial number (b)(4)).Customer is unable to advise whether or not the sample that generated false sars-cov-2 results was recollected or result was questioned by the medical staff.This result was reported to medical staff.Customer confirmed that it is the customer's policy not to report any results that are dual or triple positive results for sars-cov-2, flu a, and/or flu b without retesting with another liat or another platform.The results were not reported to medical staff.Customer confirmed that all samples that generated flu b results were retested on another liat or another platform and generated negative results.The results were not reported to medical staff.No harm was alleged.13 mdrs are being submitted.

• Brand Name: COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12183452
• MDR Text Key: 281590623
• Report Number: 2243471-2021-02523
• 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
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10304X
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1