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 Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

Review of the provided data indicated that the alleged sample is a low titer sample.The observed discrepancy is most likely due to the sample being a weak positive for the sars-cov-2 target that is at/near the limit of detection (lod) of the assay.Low viral load specimens that are near the assay lod may not generate consistent results upon repeat testing according to expected statistical variances in detection.This is a sample specific issue and the reagent is performing as intended.The customer is also using an off-label collection kit.Using an off-label collection kit in which the volume of collection media is not identical to the on-label collection kit (3ml) can affect the performance of the assay.If a collection kit is used that has a lower volume of media, then any potential interfering substances collected will be more concentrated.If there is a high level of interfering substances present in the sample (blood, mucous, etc.) then this could have a negative impact on assay performance including delayed ct values and lower amplification.In the case of a weak sample, the target may not be seen at all by the test.

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 discrepant results for one patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged sample initially generated a positive result for sars-cov-2 (negative for influenza a&b).The same sample was retested on another assay (genexpert) and generated a negative result for sars-cov-2.A recollected sample, a second recollected sample, and another sample (unknown if original or one of the recollected samples) for the same patient were tested on a different liat analyzer and generated a negative result for all targets.The second recollected sample was also tested on another assay (ausdx platform) and generated a negative result for sars-cov-2.The initial positive result was reported.No harm was alleged.An investigation was conducted to evaluate the customer issue.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; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 17994939
• MDR Text Key: 326369525
• Report Number: 2243471-2023-03408
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): Y
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 09211101190
• Device Lot Number: 21128G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1