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

Catalog Number 09211101190

Device Problem Non Reproducible Results (4029)

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

Event Date 11/29/2021

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 from (b)(6) alleged discrepant results generated for one patient when using the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system compared to the retest results.The patient sample generated a positive result for the flu a target with a late ct of 32.94.The customer repeated this sample on another cobas liat analyzer and reproduced a positive result for the flu a target with a late ct of 33.64.The customer then repeated the sample on the lc480 with lightmix flu a assay twice and obtained negative results.Though requested multiple times, no information on sample type, collection kit, or which results were reported was provided.No harm was alleged.

Manufacturer Narrative

Only data from the repeat run on the cobas liat analyzer s/n (b)(4) was provided for investigation.Review of the data showed that the alleged sample was processed in run 172.The sample produced a positive flu a result with a late ct of 33.64.The curve for this run does not show any obvious abnormalities and appears to represent low-level amplification.Based on the limited data set provided, the analyzer appears to be is performing well.The data indicated the sample contains a viral target concentration at the limit of detection for the assay, so discrepancies at this level can be expected with repeat testing especially with other assays of varying sensitivity.No product problem was identified.(b)(4).

• Brand Name: COBAS® LIAT® 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: 13085439
• MDR Text Key: 290167419
• Report Number: 2243471-2021-03898
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10621Y
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/24/2021
• 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?: Yes
• Patient Sequence Number: 1