MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number 09211101190

Device Problem False Positive Result (1227)

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

Event Date 11/04/2021

Event Type  malfunction  

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 to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.The implementation of both the software and the updated script have shown a reduction in the calculated false positive rate.Consignees have been notified.(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 generated for the cobas® sars-cov-2 & influenza a/b (scfa) assay.A customer from the united states alleged that they received potential false results for patient¿s samples tested with the cobas® sars-cov-2 & influenza a/b (scfa) assay kit lot #10823z.The customer reported that on (b)(6) 2021 run (b)(6) generated a sars-cov-2 positive, influenza a positive, influenza b positive result when analyzed on the cobas® liat® system (s/n (b)(4)).The patient¿s same sample was repeat tested and analyzed on a different cobas® liat® system (s/n (b)(4)) that generated a sars-cov-2 negative, influenza a negative, influenza b negative result.Customer sent the patient¿s same sample to a lab to be tested on a different platform (platform used not provided) that generated a sars-cov-2 negative, influenza a negative, influenza b negative result.Additionally on (b)(6) 2021 it was identified that run #(b)(6) a sample tested with a different cobas® sars-cov-2 & influenza a/b (scfa) assay kit lot#10607x generated a sars-cov-2 positive, influenza b positive result when analyzed on the cobas® liat® system (s/n (b)(4)).Information regarding if the sample was repeated and if results were reported is unknown and no harm or injury was indicated.Patient sample was collected using nasopharyngeal samples in remel 4rt viral transport media.The customer confirmed there was no allegation of harm to the patient.The negative result for patient #1 was reported out to the patient and/or personnel treating the patient.Two (2) mdrs will be filed one for each sample as per fda guidance.

• Brand Name: COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B
• Type of Device: COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 12924408
• MDR Text Key: 285633974
• Report Number: 2243471-2021-03835
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10607X
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 2243471-03-17-2021-001-C
• Patient Sequence Number: 1