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 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer is using off-label collection kits, which is likely playing a major role in the issue.Review of the data did not show any signs of a systematic problem.Also, the result contains viral material near the limit of detection (lod) of the assay where results are known to waiver on repeat testing.Further investigation was performed to rule out a product quality issue.(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 slovenia 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 run #560 produced a sars-cov-2 positive, influenza a negative, influenza b negative result for a patient¿s sample analyzed on the cobas® liat® system (s/n (b)(4)).The patient¿s same sample was repeat tested run #561 that produced a sars-cov-2 negative, influenza a negative, influenza b negative result when analyzed on the same cobas® liat® system (s/n (b)(4)).Patient sample was collected from the nasopharynx and put into physiological solution.This is not a recommended practice for sample collection.As per the method sheet, collect specimen using a sterile flocked swab with a synthetic tip according to applicable manufacturer instructions and/or standard collection technique using 3 ml of viral transport media or sterile 0.9% physiological saline.The customer confirmed there was no allegation of harm to the patient.Unknown if results were reported out to the patient and/or personnel treating the patient.

• 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: 13085460
• MDR Text Key: 290564487
• Report Number: 2243471-2021-03913
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 12/24/2021

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: 06/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10720Y
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/24/2021
• 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