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 11/23/2021

Event Type  malfunction  

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 discrepant results generated with the cobas® sars-cov-2 & influenza a/b nucleic (scfa) acid test for use on the cobas® liat® system.The customer reported that on (b)(6) 2021, the initial patient sample was tested with the cobas® liat® system sn (b)(4), lot 10823u generated sars-cov-2 positive.Two new samples were re-collected and repeated with the same device and generated sars-cov-2 negative, influenza a negative and influenza b negative.Subsequently, all three samples were repeated with a different cobas® liat® system sn (b)(4), and generated negative results for all three targets.The 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.

Manufacturer Narrative

Causal factor / root cause: the internal control amplification for all three runs was robust, with no signs of pcr inhibition.Run # (b)(4) has a very weak target amplification with a late ct.Furthermore, a system assessment found that the target amplification is not motivated by either the optical or motion disturbances.The run meets the characteristics of a sample with a low titer, near the limit of detection (lod) for the test.Samples near the lod, sample results can be expected to waiver upon retest.No product problem related to the customer allegation was identified.(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: 13056269
• MDR Text Key: 282636094
• Report Number: 2243471-2021-03871
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/21/2021

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: 07/31/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 10823U
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/21/2021
• 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