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 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

A problem report from the liat (b)(4) was provided and found that the alleged sample: on (b)(6) 2021, run (b)(6), scfa lot 11004z, generated sars-cov-2 positive with a ct=36.3, influenza a&b negative.No data for the recollected test result was provided.The late sars-cov-2 ct-value indicates a low viral load sample near the limit of detection (lod) of the assay.Note that samples near or below the lod of the test may generate wavering results upon repeat testing.In addition, sample to sample variability can occur due to: when sample was collected in relation to disease course (pre-symptomatic, or as infection descends to lungs/or patient recovers); how sample was stored prior to testing (sample degradation); or inadequate sample collection.While it is difficult to specify a cross-contamination as a cause.Nonetheless, it is a possibility.Please ensure good lab practices are in place to reduce this chance.Additionally, of note is the unknown collection kit in use.Media with a different chemical composition could contain substances that could interfere with test operation and may impact assay performance.The approved on-label collection kits have been tested and confirmed to be compatible with the scfa assay.Validated collection media kits for each specimen type can be found in the method sheet and are recommended for optimal performance of the assay.Further investigation was performed to rule out a product quality issue.No product problem found.(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 a discrepant result with the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test for use on the cobas® liat® system.The customer reported that the initial test with the cobas® liat® sn (b)(4), generated sars-cov2 positive, influenza a negative and influenza b negative.A new sample was re-collected and repeated with a different cobas® liat® was negative for all 3 targets.Both positive and negative results were reported to the patient and or/ medical personnel treating the patient.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.

• 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: 13082076
• MDR Text Key: 286671403
• Report Number: 2243471-2021-03895
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 11004Z
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• 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?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male