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 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

There was no systematic issue observed and no product problem found throughout the data analysis.The late ct value on runs #(b)(6) indicates samples at the limit of detection (lod) where results are known to waiver on repeat testing.There are no indications that a system's issue could have contributed to the complained discrepant results.Overall, the most likely cause for the discrepant results may be due to a sample handling issue or cross-contamination.A systematic issue is not suspected.(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 alleged discrepant results for 2 patient samples when using the cobas® sars-cov-2 & influenza a/b test assay for use on the cobas® liat® system.On (b)(6) 2022, patient 1, initially tested sars-cov-2 positive, influenza a&b negative.The same sample was repeated twice the same day; once on a separate cobas liat analyzer and resulting in negative on all 3 targets.On (b)(6) 2022, the same sample was further retested on the same cobas liat analyzer used for the initial test and generated a sars-cov-2 positive, influenza a&b negative result.On (b)(6) 2022, patient 2, initially tested sars-cov-2 positive, influenza a&b negative upon repeat testing of the same sample on a separate cobas liat analyzer on the same day, the sample generated a negative result for all 3 targets.On (b)(6) 2022, the same sample was retested again the same cobas liat analyzer used for the retest and generated a negative result for all 3 targets.The sars-cov-2 positive results were reported to both patients.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.Per fda¿s eua guidance, 2 mdrs 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 14407121
• MDR Text Key: 300213299
• Report Number: 2243471-2022-00475
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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: 20131X
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• 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