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

Catalog Number 09233474190

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 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

A batch mdr is being submitted to represent all the samples on a given run.This will represent one event on a single device as per fda guidance.No product problem or systemic issue was identified and the likely cause is sample specific factors.Based on the data provided and the allegation, the likely cause of the discrepancy is that the customer retested samples near the limit of detection (lod) of the assay.Samples near the lod can waiver between positive and negative during repeat testing.Other potential causes/ contributing factors that cannot be ruled out are potential contamination/ sample swap.The controls performed consistently across both runs and the control curves did not show any major shifts or suppression.The ic performed consistently throughout the entire runs.No product problem or systemic issue 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 from south korea alleged discrepant results for 5 samples when testing with the cobas® sars-cov-2 & influenza a/b qualitative assay for use on the cobas® 6800/8800 systems.The alleged 5 samples were run on cobas® 6800 (sn: (b)(4)) and generated negative results for all targets.The same 5 samples were repeated on another cobas® 6800 (sn: (b)(4)) and generated positive results for target 2 (sars-cov-2) and target 3 (pan-sarbecovirus).The results were reported to the patient and or/ medical personnel treating the patient.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.Per fda¿s eua guidance, a batch mdr is being submitted to represent all the samples on a given run.

• Brand Name: COBAS® 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: 14151128
• MDR Text Key: 298954396
• Report Number: 2243471-2022-00416
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EUA202635
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09233474190
• Device Lot Number: H25518
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1