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 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

The customer is using treidila swab for sample collection which is off-label.Note that as per the instructions for use, inadequate or inappropriate sample collection, storage, and transport may yield incorrect or invalid test results.It is also possible that the discrepancy might have occurred due to the differences in sensitivity and detection technologies between the competitor assays and the cobas liat.Within the data provided by the customer, only the 2 runs for patient 1 could be identified.Review of the dataset identified that the internal control (ic) of both runs is within range and does not show any signs of a systematic issue, with that being said the ic for one of the run is slightly delayed which might indicate a slight inhibition that may have arisen from the sample quality due to the off-label collection the customer is using.Additionally, in the curves of the runs, a slight but not strong enough amplification can be observed for the flu a target which may indicate that the samples have a low viral concentration that is below the test's limit of detection (lod).Upon a holistic review of the dataset provided for 3 different cobas analyzer provided by the custoemr (s/n (b)(4), the background and baseline levels are stable and do not show any signs of an 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 australia alleged a discrepant results for three patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged samples initially generated negative results for influenza a when tested on the cobas® liat® system (negative for sars-cov-2 and influenza b).One of the patient samples was retested on the liat, which further generated a negative result for influenza a(negative for sars-cov-2 and influenza b).The same samples were retested on two different platforms (genexpert and ausdx) which yielded a positive influenza a result for all three samples.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 3 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 14606233
• MDR Text Key: 300808612
• Report Number: 2243471-2022-00538
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 09211101190
• Device Lot Number: 20207Y
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• 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