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); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

A customer from australia alleged discrepant results while using the cobas® sars-cov-2 & influenza a/b nucleic acid test for use on the cobas® liat® system.An investigation was performed to evaluate the customer issue.Data was provided and reviewed and it was seen that run #810 produced a positive result for the sars target with a delayed ct of 36.42.The curve was representative of low level amplification in the limit of detection (lod) range.The data indicated the sample contains a viral target concentration at the limit of detection for the assay, so discrepancies at this level can be expected with repeat testing.It is possible one or multiple of the samples pooled had low-level virus present and therefore lod results were generated upon testing.The issue is sample specific and no product problem was identified.No analyzer issue was seen in the provided data set.Additionally, the practice of testing pooled samples with this test is considered off-label and not recommended.Per the ifu, "this test is intended to be used for the detection of sars-cov-2, influenza a and influenza b rna in nasal and nasopharyngeal swab samples collected in a copan utm-rt system (utm-rt) or bd¿ universal viral transport system (uvt) or thermo fisher¿ scientific remel¿ media, or thomas scientific mantacc¿ premeasured 3 ml 0.9% physiological saline solution.Testing of other sample or media types may lead to inaccurate results." it is unknown how testing pooled samples may affect results.The issue is sample specific and no product problem was identified.(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.The customer alleged discrepant results generated for the cobas® sars-cov-2 & influenza a/b (scfa) assay.A customer from australia alleged that they received a potential false positive result for a patient¿s sample tested with the cobas® sars-cov-2 & influenza a/b (scfa) assay.The customer reported that run # 810 produced a sars-cov-2 positive result from a pooled test, analyzed on the cobas® liat® system (s/n (b)(4)).The customer separated the pool, the individual samples from the pool produced a sars-cov-2 negative result analyzed on the cobas® liat® system (s/n (b)(4)).The pooled samples from run # 810 was repeat tested and analyzed on a different cobas® liat® system (s/n not provided) that generated a sars-cov-2 negative result.No patient details were made available, and no harm or injury was indicated.No information on sample collection or handling was provided.

• 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: 13081825
• MDR Text Key: 290561527
• Report Number: 2243471-2021-03893
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10628X
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/23/2021
• 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