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 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 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed on the reagent kit lot and no product problem was identified.Further investigation is ongoing in order to identify the root cause of the customer allegation.A follow-up mdr will be filed upon completion of the investigation.(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 alleged discrepant results when using the cobas® sars-cov-2 & influenza a/b test on the cobas® liat® system.Initial run of the sample was invalid and retest generated positive results on all 3 targets (sars-cov-2, flu a and flu b).Repeat testing of the same sample was performed as a sent-out to a sister site and was tested on their cobas® liat® system.This test generated negative results for all 3 targets of sars-cov-2 & influenza a/b.The results were released as negative to patient.No treatment was required and no harm or injury was alleged.

Manufacturer Narrative

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 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: 11418177
• MDR Text Key: 280454320
• Report Number: 2243471-2021-00459
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA201779
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 09211101190
• Device Lot Number: 00914Y
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1