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 False Positive Result (1227); Non Reproducible Results (4029)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is ongoing.Since it is not known exactly how many false positive results are being alleged by the customer, review of all positive results during the alleged date range of 01dec2021 - 08dec2021 were reviewed.A total of 34 positive sars-cov-2 runs were generated on these four analyzers during this time.No pcr curve abnormalities are seen in any runs which would indicate an erroneous result was generated.All runs show true amplification with robust pcr curves, with the exception of 3 runs which still show real amplification but with a later ct value typically considered to be near the lod of the assay.A supplemental mdr will be submitted to share the final conclusions.(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 the us alleged multiple discrepant results while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged samples initially generated a positive result for sars-cov-2 (negative for flu a and flu b).The same samples were retested on a competitor platform (denmark) and a different liat analyzer which yielded a negative result for all targets.It is unknown how many total samples are being alleged by the customer.The initial positive results were released to the patients but it is it unknown if harm is alleged at this time.Upon review of the data provided, a patient sample was identified to have generated a positive result for sars-cov-2 during the initial testing using cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.A retest was performed a day later on a different liat analyzer and generated a negative result for all targets.An investigation is underway to evaluate the customer issue.Given that the total number of samples alleged is unknown but that first review of the data identified discrepant results for one patient, one (1) mdr will be submitted.

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 the us alleged discrepant results for 3 samples while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system forfive samples.The alleged samples initially generated a positive result for sars-cov-2 (negative for flu a and flu b).Two of these same samples were retested on a competitor platform (genmark eplex) and a different liat analyzer which yielded a negative result for all targets.One of these same sample was only retested on a competitor platform (genmark eplex) which yielded a negative result for all targets.The initial positive results were released to the patients.No harm alleged.Three mdrs will be filed, per fda eua guidance.

Manufacturer Narrative

An investigation concluded that no abnormalities were seen for these runs which would indicate an erroneous result was generated.The positive runs show true amplification with robust pcr curves, with the exception of run # 6174 (sample #2), which still shows a real amplification, but with a later ct value typically considered to be near the test's limit of detection (lod).For sample 1, the discrepancy between the liat results may be due to sample handling as no issues were identified with either run that may indicate erroneous results.The discrepancy between the liat and the genemark eplex may be due to the differences in sensitives as well as detection technologies.Updated b6 and b5 to reflect the total of 3 discrepant results alleged.Updated b3.(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: 13085450
• MDR Text Key: 290793486
• Report Number: 2243471-2021-03907
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• 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: 10706Y
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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