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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

A customer from the us filed a complaint when using the cobas® sars-cov-2 & influenza a/b test on the cobas® liat® system sn: (b)(4).Review of the instrument data identified 15 samples had false positive flu b results.An investigation to evaluate the customer issue 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 and the udi is (b)(4).-- (b)(4).

Event Description

In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer from the us filed a complaint when using the cobas® sars-cov-2 & influenza a/b test on the cobas® liat® system sn: (b)(4).Review of the instrument data identified 15 samples had false positive flu b results.Per fda guidance, 15 mdrs will be filed, one per alleged sample.According to the customer, samples are normally collected by nurses using nasopharyngeal swabs and utm media.However, due to short supply, the customer started using avantik collection kits for some samples.Note, use of the avantik collection kit is not considered a recommended practice.According to the method sheet, specimens should be collected using: a sterile flocked swab with a synthetic tip according to applicable manufacturer instructions and/or standard collection technique using 3 ml of viral transport media or sterile 0.9% physiological saline.A review of the data revealed a tube leak which likely obstructed the optical path resulting in false detection of the flu b analyte.An investigation to evaluate the customer issue is ongoing.

Manufacturer Narrative

The customer's cobas liat analyzer was returned for further 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 between april - june 2021.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: 11369305
• MDR Text Key: 234800318
• Report Number: 2243471-2021-00376
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 07341920190
• Device Lot Number: 00819Y
• 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