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 Non Reproducible Results (4029)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation concluded that this run shows strong amplification in the sars-cov-2 channel.Review of the pcr curves for this run show no abnormalities which would usually indicate an erroneous result was generated; a strong sigmoidal curve can be seen in the sars-cov-2 channel, indicating that amplification has occurred.Please note differences in testing technologies could contribute to sample discrepancies, including limit of detection (lod) and genes targeted.As such, results of one assay may not reproduce on another assay.Additionally, the scfa assay method sheet recommends to collect specimen using a sterile flocked swab with a synthetic tip using 3 ml of viral transport media according to applicable manufacturer instructions and standard collection technique.Validated collection media kits for each specimen type can be found in the method sheet.Collection kits that are not recommended in the method sheet could affect the performance of the assay.The reagent lot was also investigated and no product problem was found.(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 from new zealand 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.Customer collected the sample using the citoswab virus collection and transport kits, 3ml utm, which is an off-label kit.The alleged sample initially generated a positive result for sars-cov-2.The same sample was retested on two different competitor platforms which yielded a negative result for sars-cov-2.Note that one of the platform detected enterovirus.Both positive and negative results were reported to the patient who is a hcp being tested routinely.No harm was alleged.An investigation was conducted to evaluate the customer issue.

• 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: 12928903
• MDR Text Key: 283087890
• Report Number: 2243471-2021-03840
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 12/03/2021

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: 06/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10712Y
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• 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