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 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.(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 the united states 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 on (b)(6) 2021 they observed a sars-cov-2 negative, influenza a negative, influenza b positive result for a patient¿s sample tested and analyzed on the cobas® liat® system (s/n14341).The patient¿s same sample was repeat tested on a different platform the cepheid that generated a sars-cov-2 negative, influenza a negative, influenza b negative result.Patient sample was collected using nasopharyngeal swab in remel universal transport media.The customer confirmed there was no allegation of harm to the patient.The negative result was reported out to the patient and/or personnel treating the patient.The investigation to assess the customer allegation has not yet been completed.

Manufacturer Narrative

Instrument data was not provided from the liat for review of instrument performance and it cannot be determined if these samples may have been near the limit of detection (lod) for the influenza b on the scfa assay.The influenza b lod differs significantly between the cobas® sars-cov-2 & influenza a/b test on the cobas® liat system and the cepheid which could explain the sample discrepancies.The lod for cepheid is claimed at 0.19 (victoria) - 0.4 (yamagata) tcid/50ml (depending on the strain).The scfa package insert indicates that the cobas® liat system influenza b lod is 0.002 (brisbabe and florida) - 0.004 (malaysia) tcid/50ml (depending on the strain), which indicates a much more sensitive test versus the cepheid.In addition, the influenza b strains detected can vary from one platform to another.As such, results with one assay may not be reproducible with a different assay.The customer states they believe the issue was due to an expired lot in use that is now discarded.They request the investigation be closed.Although requested, no further information was provided on the lot in use at the time of the allegation.Customer claims they used an expired assay kit.Differences in testing platforms could also contribute to the discrepancy.(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: 13026524
• MDR Text Key: 287813850
• Report Number: 2243471-2021-03862
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 09211101190
• Device Lot Number: 01214U
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• 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 Age: 62 YR
• Patient Sex: Female