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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

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 alleged a discrepant result for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The first sample was run on liat s/n (b)(4) and generated initial results of positive sars-cov-2, positive influenza a and negative influenza b.This original sample, stored at 2-8c, was retested the following day with the cepheid and resulted negative sars-cov-2, positive influenza a and negative influenza b.The next day a recollected sample from the same patient was ran on liat s/n (b)(4) and resulted positive sars-cov-2, positive influenza a and negative influenza b.This sample was reran the same day on the cepheid as negative sars-cov-2, positive influenza a, negative influenza b.The influenza a positive results were reported.No harm is alleged customer collects nasopharyngeal samples using bd utm catalog number 220531, which is an on-label collection.An investigation was conducted to evaluate the customer¿s allegation.Per the fda guidance two (2) mdrs will be filed one per run.

Manufacturer Narrative

Liat results correlate and review of pcr curves show no indication of false results.The differences in testing technologies could explain the sample discrepancies.The lod differs significantly between the sars-cov-2 & influenza a/b (scfa) test on the cobas® liat system and the cepheid genexpert which could explain the sample discrepancies.The lod for genexpert is claimed at 0.0200 pfu/ml.The scfa package insert indicates that the liat system sars-cov-2 lod is 0.012 tcid50/ml (0.0084 pfu/ml) which indicates being over twice as sensitive as the genexpert.Therefore, the liat system will detect sars-cov-2 when the viral load is lower then what is detectable by the genexpert.In addition to the lod differences, the type of influenza viral strains detected differs significantly between the scfa (orf1a/b along with the n gene) and the cepheid (n2 target and e target) assays.As such, results with one assay may not be reproducible with a different assay.(b)(4).

• 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: 13088387
• MDR Text Key: 290452418
• Report Number: 2243471-2021-03918
• 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
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 11011Z
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 24
• Patient Sex: Female