MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2 QUALITATIVE 480T; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 09448870190

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 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress.A follow-up report will be filed upon the completion of the investigation.A batch mdr is being submitted to represent all the samples on a given run.This will represent one event on a single device as per fda guidance.The customer issue has been alleged on the cobas sars-cov-2 qualitative test for use on the cobas 5800/6800/8800 systems ce-ivd, catalog number 09448870190 and udi (b)(4) which is not yet available in the us.The similar assay currently available in the us under emergency use authorization is the cobas sars-cov-2 test for use on the cobas 6800-8800 system (b)(4).The product catalog number for the test (480t) is 09343733190 and the udi is (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 japan alleged discrepant results for two patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged samples initially tested with the cobas liat generated sars-cov-2 positive results.The next day, new samples were collected and tested on the cobas 5800 which generated sars-cov-2 negative results.All results were reported to the patient and medical personnel.No harm was alleged.An investigation has been initiated and is ongoing.

Manufacturer Narrative

No product problem was identified.It can be concluded that the discrepant results are related to sample specific factors.The discrepant results observed likely sample specific due to the dilution of the sample or sample collection.Any collection less than 3ml can contribute to invalids and diluting a sample can contribute to false negatives depending on the amount of viral genomic material available within the tube being tested.Another contributing factor can be the fact that the samples being compared were from 2 different collections.The runs contain valid controls as well as positive and negative samples, which also indicates that a reagent problem is unlikely.

• Brand Name: COBAS® SARS-COV-2 QUALITATIVE 480T
• 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
• 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: 15075852
• MDR Text Key: 304716050
• Report Number: 2243471-2022-00615
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EUA200009
• 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,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 09448870190
• Device Lot Number: H31078
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1