MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2 & INFLUENZA A/B V2; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number 10033401190

Device Problem False Positive Result (1227)

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

Event Date 01/27/2024

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 alleged discrepant results for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test v2 on the cobas® 58/68/8800 systems.The alleged sample initially generated positive results for sars-cov-2 and influenza a.A different sample from the same patient was retested on the same assay yielded the same sars-cov-2 and influenza a positive results.The initial sample was retested on different platforms (cobas liat, luminex magpix) which yielded a negative result for influenza a.A new sample was collected and tested on the cobas 5800 twice which yielded a positive result for sars-cov-2 each time.The initial positive influenza a result was not released.No harm was alleged.An investigation is being conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

The data from the alleged sample was reviewed, showing a true positive sample with a very low influenza a titer which can generate wavering results during retesting.No product problem identified.Note, that the customer used off-label pharyngeal wash as a sample.Per the method sheet, the intended sample types are healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider).Medwatch fields d4 lot no and d4 expiration date have been updated.

• Brand Name: COBAS® SARS-COV-2 & INFLUENZA A/B V2
• 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 ; 9253534412
• MDR Report Key: 18779260
• MDR Text Key: 337295378
• Report Number: 2243471-2024-00546
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EUA230046
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10033401190
• Device Lot Number: K20492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1