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 09446125190

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 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

No data was provided for review and analysis.Without data (including lot information), sample specifics, or patient information a complete analysis could not be completed.Although the root cause cannot be confirmed due to a lack of information, it is likely that the discrepancy is related to the differences in technology.It can be concluded based on the fact that the positive result was repeated 2x with the same sample that a product problem is unlikely.The reason for the discrepant results is sample specific, either due to differences in technology including the sensitivity of the assays, or the difference in sample type/collection as a new sample was collected and tested at the unspecified hospital.The sars-cov-2 detection kit on smart gene system, manufacturer mizuo medy co.Ltd.Is a rapid test and may not be as sensitive.The customer issue has been alleged on the cobas sars-cov-2 & influenza a/b qualitative assay for use on the cobas 5800/6800/8800 systems ce-ivd, catalog number 09446125190 and udi (b)(4) which is not yet available in the us.The similar assay currently available in the us under emergency use authorization is the cobas sars-cov-2 & influenza a/b qualitative assay for use on the cobas 6800/8800 systems (eua202635, product code: qlt).The product catalog number for the test (384t) is 09233474190 and the udi is (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 japan alleged discrepant results while using the cobas® sars-cov-2 & influenza a/b test for use on the cobas® 5800/6800/8800 systems.5 pooled samples were run on cobas 8800 and generated a positive result for sars-cov-2.The 5 pooled samples were individually tested on the cobas 6800 and 1 sample generated a positive result for sars-cov-2.The following day, a new sample was collected from the patient that generated the positive result and was run a competitor platform (sars-cov-2 detection kit on smart gene system, manufacturer mizuo medy co.Ltd.) which yielded a negative result for sars-cov-2.The results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr 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; na; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16152765
• MDR Text Key: 308418425
• Report Number: 2243471-2023-00039
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09446125190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• 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