MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS LIAT SYSTEM; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Catalog Number 07341920190

Device Problem False Positive Result (1227)

Patient Problems Anxiety (2328); Respiratory Tract Infection (2420); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

A customer in (b)(6) alleged the generation of false positive results for 2 patient samples when tested with the cobas liat analyzer.It was noted the customer retests their positive samples on another cobas liat analyzer.No further details or data were provided.No harm was indicated.Two mdrs will be filed, one for each patient sample.

Manufacturer Narrative

The investigation is on-going.Supplemental reports will be filed upon completion of the investigation.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system ((b)(4), product code: qjr).The product catalog number for the test is 09211101190 and the udi is (b)(4).(b)(6).(b)(4).

Manufacturer Narrative

Roche has received an increased number of complaints from customers when using cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system, lot 10119z.Customers are alleging an increased number of initial positive sars-cov-2 results that were negative upon retests on the same platform and/or on other platforms.Investigative testing using returned kits from the field generated an unexpected sars-cov-2 positive rate of 7% with known negative samples.Considering the involved hazards of the issue, there is a remote probability that use of the affected reagent lot will lead to adverse events in populations at greatest risk for infectious complications due to false positive sars-cov-2 results.Adverse health consequences are otherwise not likely.Consignees have been notified to immediately discontinue the use of and discard any remaining inventory of the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system, lot 10119z.(b)(4).

• Brand Name: COBAS LIAT SYSTEM
• Type of Device: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12029661
• MDR Text Key: 281010122
• Report Number: 2243471-2021-02056
• Device Sequence Number: 1
• Product Code: OCC
• Combination Product (y/n): N
• PMA/PMN Number: K111387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07341920190
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243471-07-28-2021-002-C
• Patient Sequence Number: 1