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 Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/19/2023

Event Type  malfunction  

Manufacturer Narrative

The root cause of the discrepant results for sars-cov-2 could not be determined without the raw data.While sample ids were provided for 22 samples, the data or lot information was not available to be provided for the alleged samples.No specific information relating to patients or runs was provided, therefore, 1 mdr was filed.

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 japan alleged discrepant results for 22 samples with the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.13 samples initially generated a positive result for sars-cov-2 when tested on the cobas® liat.The samples were repeated on the cobas® sars-cov-2 qualitative nucleic acid test for use on the cobas® 5800 system and generated a negative result for sars-cov-2.9 samples initially generated a negative result for sars-cov-2 when tested on the cobas® sars-cov-2 qualitative nucleic acid test for use on the cobas® 5800 system.The samples were repeated on the cobas® liat and generated a positive result for sars-cov-2.1 sample initially generated a positive result for sars-cov-2 when tested on the cobas® liat.The sample was repeated on the cobas® sars-cov-2 qualitative nucleic acid test for use on the cobas® 5800 system and generated a negative result for sars-cov-2.The sample was again repeated on the cobas® liat as sars-cov-2 positive.The samples for the cobas® liat and the samples for the cobas® 5800 were separate samples.The results were reported.No harm is alleged.

• 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: 16974484
• MDR Text Key: 315853916
• Report Number: 2243471-2023-00234
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09211101190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• 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