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 False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in progress.A follow-up report will be filed upon the completion of the investigation.Facility name truncated due to character limit: (b)(6).(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 thailand alleged a discrepant result for a single 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 when tested on the cobas liat (s/n (b)(4)).The same sample was retested on the same cobas liat and the cobas 6800 which yielded negative results.No harm was alleged.An investigation has been initiated and is ongoing.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

Although the root cause cannot be identified, true amplification was observed.The dataset was reviewed and it can be concluded that all system-related parameters are within the expected range and it can be excluded that the analyzer was contributing to a discrepant result.For the sample provided on run 2530, the positive called result, the ct, and the strong amplification are accurate and correct from a system perspective.There are no signs of a systematic issue.Alleged kit lot 20207l was internally tested and the customer allegation was not identified.--------------------- -changed device code from false positive result to non reproducible results.---------------------.

• 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: 14606042
• MDR Text Key: 301160625
• Report Number: 2243471-2022-00536
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 06/29/2022

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: 20207L
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• 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