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

Catalog Number 09211101190

Device Problem False Positive Result (1227)

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

Event Date 07/20/2023

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 from the united states alleged discrepant results while using the cobas® sars-cov-2 and influenza a/b nucleic acid test on the cobas® liat® system.During the review of the data provided, a single potential false-positive result was identified.Run# 3984 generated a positive result for sars-cov-2.It is unknown if the sample was repeated.It is unknown if the results were reported.No harm alleged.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

Analyzer was returned and will be sent to the repair depot for service.Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 and 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 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 and 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.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 and influenza a/b test for use on the cobas liat system (b)(4) product code: qlt).The product catalog number for the test is 09211101190 and the udi is (b)(4).

• Brand Name: COBAS® SARS-COV-2 AND 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; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 17602994
• MDR Text Key: 321734039
• Report Number: 2243471-2023-02733
• Device Sequence Number: 1
• Product Code: OCC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K111387
• 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: 08/23/2023

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: 09/30/2023
• Device Catalogue Number: 09211101190
• Device Lot Number: 21017T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES87622
• Patient Sequence Number: 1