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 09/20/2023

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 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 negative result for all targets (sars-cov-2 and influenza a&b).The same sample was retested on another assay (genexpert sars-cov-2/flu/rsv plus) and generated a positive result for sars-cov-2.The same sample was stored overnight and then retested on a different liat analyzer which was negative for all targets, and the genexpert sars-cov-2/flu/rsv plus assay which was positive for sars-cov-2 the initial negative result was reported and then amended.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

For the retest on 21-sep-2023, it was observed that the sample was stored improperly overnight which may have led to some degree of sample degradation.Based on the data analysis review, the product is performing as intended.A result discrepancy may be expected between assays due to potential differences in the tests¿ limits of detection (lod) and intended use.Note that not following the method sheet for sample storage likely caused sample degradation.---- lot 30103g expiration date: 6/30/2024.Lot 21205f expiration date: 5/31/2024.

• 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: 17883871
• MDR Text Key: 325077526
• Report Number: 2243471-2023-03208
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09211101190
• Device Lot Number: 30103G,21205F
• 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