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 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

Throughout the data analysis, a systematic issue was not observed and a product problem was not found.The most likely cause for the discrepancy observed is due to the variations from sample to sample during collection.Sample to sample variability can occur due to: when sample was collected in relation to disease course (pre-symptomatic, or as infection descends to lungs/or patient recovers); how sample was stored prior to testing (sample degradation); or inadequate sample collection.Comparison of two samples collected at different times may yield varying results.Further investigation was performed, including on the two reagent lots used, and ruled out a product quality issue.(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 taiwan alleged discrepant results for one patient sample when using the cobas® sars-cov-2 & influenza a/b test assay for use on the cobas® liat® system.The customer collected nasopharyngeal samples using either cmp 3ml transport media catalog number cmp0404361, or iron will utm, catalog number utm-32501.4.1, which are both an off-label collection.On (b)(6) 2022, the initial sample was tested with cobas® liat® (s/n (b)(4)) and generated a sars-cov-2 positive, influenza a negative, influenza b negative result.On (b)(6) 2022, a sample was re-collected and tested with cobas® liat® (s/n (b)(4)) and generated a negative result for all targets.On (b)(6) 2022, a third sample was collected and tested with cobas® liat® (s/n (b)(4)) which generated a sars-cov-2 positive, influenza a negative, influenza b negative result.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.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: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 14135166
• MDR Text Key: 298888401
• Report Number: 2243471-2022-00407
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 20104X
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• 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