MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 09211101190

Device Problems False Positive Result (1227); Gas Output Problem (1266); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A customer from (b)(6) questioned results for 6 patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test across two cobas® liat® systems.No harm was alleged.An investigation has been initiated and is ongoing.(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 denmark questioned results for several patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test across two cobas® liat® systems.No harm was alleged.A total of 6 patients were affected, accordingly 6 mdrs will be filed per fda guidance.Originally, the customer questioned discrepant results on analyzer (b)(4) which affected 2 patients.Patient 1 initially generated a positive sars-cov-2 result but was later negative when two new samples were collected and tested on the same platform.Patient 2 was positive for sars-cov-2 a total of 3 times each with new samples across two analyzers but negative with additional repeat testing.The customer also questioned positive sars-cov-2 results for 4 more patients on analyzer (b)(4).According to the customer, several of patients were retested and generated negative results.However, there is no available information to identify which patients received additional testing.An investigation has been initiated and is ongoing.

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.Corrected device code from non-reproducible results to false positive result.(b)(4).

• Brand Name: COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12095891
• MDR Text Key: 281008296
• Report Number: 2243471-2021-02234
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA201779
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 09211101190
• Device Lot Number: 10119Z
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: 2243471-07-28-2021-002-C
• Patient Sequence Number: 1