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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 06/17/2022

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 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 influenza b.The sample was retested on a different cobas liat (sn: (b)(4) and on a competitive device (denka influenza rsv rapid diagnostic test (denka co.Ltd)) which yielded negative results.The negative result was reported out.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

Upon review of the curve generated for the positive result, true amplification can be observed in the flu b channel.Note that the amplification, as well as the ct value generated, is delayed which indicates the sample has a low viral concentration near the test's limit of detection (lod).Overall, both instruments, sn (b)(4) and sn (b)(4) are working as intended and do not show any signs of a systematic issue.Furthermore, the alleged reagent kit 20207l was previously internally tested and the allegation was not observed.The alleged sample is near or below the lod of the assay which may generate wavering results.Additionally, it is possible that there was contamination from a highly positive sample that was tested twice on the same analyzer approximately an hour prior to this sample.

• 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: 14976810
• MDR Text Key: 304595491
• Report Number: 2243471-2022-00599
• 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
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 06/17/2022
• 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
• Patient Age: 43 YR
• Patient Sex: Male