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 Non Reproducible Results (4029)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

Review of the provided data showed that patients 1, 3, and 5 are low titer samples.The observed discrepancy is most likely due to the samples being a weak positive for the sars-cov-2 target that is at/near the limit of detection (lod) of the assay.Low viral load specimens that are near the assay lod may not generate consistent results upon repeat testing according to expected statistical variances in detection.For patients 2 and 4, strong amplification was observed.The discrepancy is likely due to the difference in sensitivities between the assays.

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 alleged discrepant results for five patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged samples initially generated a positive result for sars-cov-2 (influenza a/b negative).Patient 1 was repeated on the same cobas liat analyzer and generated all negative results.Per the customer, all 5 samples were repeated on competitor pcr tests (mizuho medy, smartgene) and antigen tests (sysmex, sars-cov-2 antigen test hiscl) and generated discrepant results but specific results were not provided.The initial positive results were not released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 5 mdrs will be filed.

• 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; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 18689054
• MDR Text Key: 336403379
• Report Number: 2243471-2024-00409
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): Y
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 30223H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1