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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 01/09/2022

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 the us alleged discrepant results for two patients' samples when using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The customer reported that on (b)(6) 2022, the initial sample for patient 1 tested with cobas liat generated influenza b positive, sars-cov-2 negative and influenza a negative results.The same sample was repeat tested on the same cobas liat analyzer and on a different platform (genexpert).Both retests generated negative results across all targets.The negative results were reported.On (b)(6) 2022, the initial sample for patient 2 tested with cobas liat generated negative results for sars-cov-2, influenza a&b.Per lab policy, due to the patient exhibiting respiratory symptoms, the patient was retested on a different cobas liat analyzer and on a different platform (genexpert).Both generated a sars-cov-2 positive result, and the positive results were reported.A viral respiratory panel was ordered, with results unknown.The customer collected nasopharyngeal samples using the bd vtm 3ml.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.Per fda guidance on eua, two (2) mdrs will be filed.

Manufacturer Narrative

Throughout the data analysis, a systematic issue was not observed and a product problem was not found.Review of the data showed normal pcr curves, without any abnormalities typically associated with erroneous results.The discrepancy for both patients show a weak amplification and late ct values, which could be explained by a low titer sample.Samples near or below the limit of detection (lod) of the test may generate wavering results on repeat testing.Viral material near the lod can be caused either from low titer samples or a low level of laboratory contamination.In addition, the lod and the type of influenza and sars-cov-2 viral strains detected differs significantly between the cobas® sars-cov-2 & influenza a/b assay on the cobas® liat® system and the cepheid genexpert assays.As such, results with one assay may not be reproducible with a different assay.An investigation was performed on the reagent lots used and ruled out any contribution.The most likely cause for the discrepancy observed is due to the sample having a low viral load where results are known to waiver and the differences in testing methods.(b)(4).

Manufacturer Narrative

Replaced incorrect code unexpected therapeutic results (a0909) with output problem (a09).(b)(4).

• 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: 13366095
• MDR Text Key: 295611297
• Report Number: 2243471-2022-00142
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 11028T
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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?: Yes
• Patient Sequence Number: 1