MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number 09211101190

Device Problem Non Reproducible Results (4029)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

A nasopharyngeal sample was collected in bd uvt, 3 ml (cat 220220), which is equivalent to the recommended media per the method sheet.The customer confirmed that the patient had not received the intranasal flu vaccine, so this is ruled out as a potential cause of the dual positive results.Dual infections are not common, but they are possible.Internal control amplification for the alleged run is robust and there are no signs of pcr suppression.Both targets have late cts and weak amplification and are consistent with a low titer sample, near the limit of detection (lod) for the liat® test.Samples that are near the lod may not generate consistent results upon repeat testing.Additionally, due to inherent differences in technologies, results between different assays may vary; one hundred percent agreement should not be expected.Alternatively, it could be possible that the results were due to cross-contamination of one or both targets.However, there are no strong indications that this occurred, as the data does not contain any positive controls or high titer samples.The reagent lot used was also investigated and ruled out any contribution to the allegation.(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 the us 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.No harm was alleged.The alleged sample initially generated a dual positive result for flu a and flu b.The same sample was retested immediately on a different platform which yielded a negative result for all targets.The positive and negative results were reported.An investigation was conducted to evaluate the customer issue.

• Brand Name: COBAS® LIAT® 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: 12921836
• MDR Text Key: 286146142
• Report Number: 2243471-2021-03817
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201779
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10907Z
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female