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 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A follow up report will be filed with the outcome 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.The customer alleged discrepant results on the cobas® sars-cov-2 assay on the liat system.A customer from united states alleged discrepant results for three patients.The customer reported that patient 1 test run #(b)(6) for sars-cov-2 & influenza a/b assay was reported as false positive for the three targets.The customer retested using the same patient sample on a different analyzer which generated negative results for the three targets.The customer confirmed they reported the negative results for sars-cov-2 & influenza a/b from the repeat run on the different analyzer.The positive results from the initial run were not reported, the customer confirmed that there was no harm to the patient or no delay in treatment.Patient 2 test run #(b)(6) generated false positive results for influenza b this was the only test run for the patient.Patient 3 test run #(b)(6) for sars-cov-2 & influenza a/b assay was reported as false positive for the three targets this was the only test run for the patient.Patient sample was collected using 3ml utm jiangsu rongye and copan flocked synthetic swab.The negative results were reported to the patient or medical personnel treating the patient.The customer confirmed that there was no allegations of harm to the patient or no delay in treatment.The investigation to assess the customer allegation has not yet been completed.3 mdrs will be filed, one for each of the patient reported test results.

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: 11418018
• MDR Text Key: 280457276
• Report Number: 2243471-2021-00457
• 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: 00928Y
• 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