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 11/21/2021

Event Type  malfunction  

Manufacturer Narrative

Data was provided and reviewed and it was observed that run (b)(6) produced a positive sars result with a ct of 37.1.This ct value indicates very low level virus present and the curve does not appear to have any abnormalities.Overall, nothing was seen to indicate the analyzer may be performing sub-optimally.Hence the data set only included 6 runs, indication that the sample contained a viral target concentration at the limit of detection of the assay.Therefore, discrepancies at this level can be expected with repeat testing.The issue is sample specific and no product problem was identified.(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 alleged a discrepant result generated with the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test for use on the cobas® liat® system.The customer reported that the initial test generated sars-cov-2 positive.The same sample was repeated with the genexpert cepheid generated negative results for all 3 targets.The negative results were reported to the patient and or/ medical personnel treating the patient.No apparent harm or injury occurred in relation to the event.The customer collected a deep throat saliva in swen brand vtm sample, which is considered an off label practice.The method sheet indicates that ; 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 thomas scientific mantacc¿ premeasured 3 ml 0.9% physiological saline solution.Testing of other sample or media types may lead to inaccurate results.An investigation was conducted to evaluate the customer¿s allegation.

• 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: 13056256
• MDR Text Key: 285843546
• Report Number: 2243471-2021-03870
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 10802Y
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• 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: 45 YR
• Patient Sex: Female