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 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

A customer from (b)(6), alleged a discrepant result generated on one pooled sample (10 samples were pooled together for testing) while using the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test, for use on the cobas® liat® system.The instrument data was provided and reviewed.The alleged runs were identified as sars-cov-2 positive results with ct values 30.2 and 34.9.A system assessment also indicated that the instrument background and baseline levels were stable throughout the dataset, with no indication of optical path contamination.Furthermore, none of the positive called runs included in the dataset could be identified as a potential false positive.In addition, the amplification for all the runs was not provoked by either motion or optical disturbance.The instrument is performing as expected.It is possible that the sample in question was at the limit of detection (lod) of the assay where results are known to waiver.Very low viral load specimens that are near the lod may not generate consistent results upon repeat testing according to expected statistical variances in detection.Low titer samples can also occur due to cross-contamination.Practicing pool multiple samples, increase the chances of contamination during sample handling.Good lab practices should be followed to minimize this chance.The allegation is not substantiated.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 from australia, alleged a discrepant result generated on one pooled sample (10 samples were pooled together for testing) while using the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test, for use on the cobas® liat® system.The customer reported 1 sample generated sars-cov-2 positive, from a pool of 10 samples that were tested with cobas® liat® system serial number (b)(4).Although no sample id was provided, the customer presumed it to be run #130 or 140.A repeat testing of the 10 samples performed individually using another cobas® liat® system was negative for sars-cov-2.No additional details on sample id were provided.The individual negative results were reported.Note that testing pooled samples is not a validated procedure and it is considered off-label practice.No apparent harm or injury occurred in relation to the event.The customer collected nasopharyngeal or oropharyngeal samples, however, no further information on sample collection was provided to indicate whether an off-label collection kit was used.The customer also stated that they are aware that pooling samples for testing is an off-label use of the cobas® liat instrument.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: 12940244
• MDR Text Key: 287283450
• Report Number: 2243471-2021-03842
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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
• Date Manufacturer Received: 11/07/2021
• 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