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 Death (1802); Anxiety (2328); Test Result (2695); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be submitted upon completion of the investigation.Msa assessment specific to patient (b)(6): if the patient in fact died that same day, clinically it is improbable that a new exposure to covid (if any, due to being placed in covid ward) would have contributed.Facility name was truncated due to character limitations.The customer site name is (b)(6).------ (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 in belgium alleged false positive results when using cobas liat sars-cov-2/flu (scfa) assay: patient (b)(6), performed on (b)(6) 2020, generated "flu a detected, flu b detected, sars-cov-2 detected" results.The sample was collected in bioermedium viral transport medium (clear medium).Nasopharyngeal swab sample was noted to be lightly bloody.Patient (b)(6) performed on (b)(6) 2020, generated "flu a detected, flu b not detected, sars-cov-2 detected" results.The sample was collected in bioermedium viral transport medium (clear medium).Nasopharyngeal swab sample was noted to be bloody.Per the instructions for use, this test is intended to be used for the detection of sars-cov-2, influenza a and influenza b rna in nasal and nasopharyngeal swab samples collected in a copan utm-rt system (utm-rt) or bd universal viral transport system (uvt) or thermo fisher scientific remel media,or 0.9% physiological saline solution.Testing of other sample or media types may lead to inaccurate results.Both samples have abnormal pcr curves with the scfa test.When retesting the original samples on different platforms (genexpert and seegene) negative results were noted.The customer's concern is specific to potential patient exposure to covid-19 after being placed in a covid ward of the hospital due to a positive test result.

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: 11032047
• MDR Text Key: 222938391
• Report Number: 2243471-2020-00508
• 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: foreign,health professional
• 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: 12/17/2020
• 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: 09211101190
• Device Lot Number: 00803X
• 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