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); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 02/26/2022

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 5 patient samples using the cobas® sars-cov-2 & influenza a/b test assay for use on the cobas® liat® system.The customer reported the 5 patient samples were processed on cobas® liat® system serial number (b)(4) and generated sars-cov-2 positive, influenza a positive, and influenza b negative results.The same samples were repeated on a different cobas® liat® (sn: unknown) resulting in a negative result for all targets.The results were not reported to the patient and/or medical personnel treating the patient.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer's allegation.Per the fda eua guidance five (5) mdrs will be filed.

Manufacturer Narrative

The amplification observed for both targets does not correlate with optical or motion disturbances.Note, the customer collected nasopharyngeal samples using jiangsu rongye technologies utm expiration 11nov2022, which is considered an off-label practice.The method sheet indicates that "this test is intended to be used for the detection of sars-cov-2, influenza a and influenza b rna in nasal and nasopharyngeal swab samples collected in a copan utm-rt system (utm-rt) or bd¿ universal viral transport system (uvt) or thermo fisher¿ scientific remel¿ media, or thomas scientific mantacc¿ premeasured 3 ml 0.9% physiological saline solution.Testing of other sample or media types may lead to inaccurate results." the most likely cause for the discrepant results may be due to sample handling issues and possible off-label collection kit used.No systemic issues are identified for lots 20110l or 11228u, and no product problem was found.(b)(4).

• 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: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 13966753
• MDR Text Key: 290076679
• Report Number: 2243471-2022-00349
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 20110L
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• 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