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 09211101190

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

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress.A follow-up report will be filed upon the completion of the investigation.H3: na.

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 thailand alleged discrepant results for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged sample initially generated a positive result for the sars-cov-2 (negative result for influenza a and influenza b).The same sample was retested on a different cobas liat analyzer and on a competitor assay (hip biotech atk test), yielding a negative result both times.The negative result was released.No harm was alleged.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

The customer¿s allegation of discrepant results, could not be reproduced in the investigation.The assay is performing within its clinically-validated claims.Potential causes of the observed discrepant results include, but are not limited to the following: ¿ contamination or non-specific amplification: cross-contamination during sample prep could introduce the target into a negative sample.In some cases, sample interferences/contaminants could cause amplification of something other than the target.¿ sample mix-up.¿ differences in technology.Device code was updated to non reproducible results.

• 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: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16852213
• MDR Text Key: 314361858
• Report Number: 2243471-2023-00218
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 09211101190
• Device Lot Number: 20912F
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• 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?: No
• Patient Sequence Number: 1