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

Event Date 04/25/2021

Event Type  malfunction  

Event Description

The customer alleged discrepant results generated from a cobas liat system.A customer from the united states alleged potentially false positive results when analyzed on the cobas liat system.The customer reported that on (b)(6) 2021 they observed a sars-cov-2 positive, influenza a positive and influenza b positive for a patient sample using the cobas® sars-cov-2/influenza a/b assay analyzed on the cobas liat system.The patient¿s same sample was repeat tested analyzed on a different liat system and generated a sars-cov-2 negative, influenza a negative and influenza b negative result.Patient sample was collected using nasopharyngeal swab and rmbio viral transport medium 3 ml.The customer confirmed there was no allegation of harm to the patient.The negative result was reported out to the patient and/or personnel treating the patient.

Manufacturer Narrative

The customer's cobas liat analyzer (s/n (b)(4)) was not requested for return.From the data assessment it was identified that a disturbance detected during run #993 to have a significant impact on baseline levels and associated with a baseline shift in the analyzer leading to the observed false positive result.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 and the udi is (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: 12029119
• MDR Text Key: 281531234
• Report Number: 2243471-2021-02027
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07341920190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1