MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Lot Number 20321U

Device Problem Non Reproducible Results (4029)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

Data was provided but did not contain the alleged samples.Based on the provided information, both samples appear to be low titer samples.Samples that are low titer may generate wavering results.Based on the available information, there is no indication of a systemic product problem and the reagents are performing as intended.No systemic product problem was identified for the alleged reagent lot.

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 canada alleged a discrepant result for a two patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.Both patients had two samples collected each.One sample was tested using the cobas sars-cov-2 nucleic acid test for use on the cobas liat system and the other was tested using the cobas sars-cov-2 qualitative assay for use on the cobas 6800/8800 systems.For patient 1, the cobas liat generated a positive result with the cobas 6800 generated a negative result for sars-cov-2.For patient 2, the cobas liat generated a negative result with the cobas 6800 generated a positive result for sars-cov-2.It is unknown which results were reported.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 2 mdrs will be filed.

• Brand Name: COBAS® SARS-COV-2
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• 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: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16281135
• MDR Text Key: 309206706
• Report Number: 2243471-2023-00095
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EUA210388
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Lot Number: 20321U
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• 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