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

Catalog Number 09343733190

Device Problems Contamination (1120); False Positive Result (1227)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated and is ongoing to evaluate the customer issue.A supplemental report will be filed upon completion of the investigation.The customer issue has been alleged on the cobas 8800 instrument, product code mza catalog number 05412722001 and udi (b)(4).The test used on the cobas 68/8800 system is the kit cobas 6800/8800 sars-cov-2 480t assay product code qjr, catalog number 09343733190 and udi (b)(4).This mdr is submitted against the kit cobas 6800/8800 sars-cov-2 480t (product code: qjr) instead of the cobas 68/8800 system, per fda request.(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 united states alleged discrepant results for 29 patient samples while using the cobas® sars-cov-2 test on the cobas® 6/8800 system.No harm was indicated.Per fda guidance, 2 mdrs will be filed, one per batch run that generated the alleged results.The customer initially ran a batch of samples that generated sars-cov-2 positive results for 8 patient samples.Later that afternoon, another batch run generated an additional 21 positive sars-cov-2 results.The customer questioned the findings and ordered a decontamination of the instrument.All samples were retested and confirmed the initial false positive results.An investigation has been initiated and is ongoing to evaluate the customer issue.

Manufacturer Narrative

A total of 29 false positive results were alleged.The evaluation of the data provided for the affected runs, however, shows 10 positive results from one batch and 24 positive results from the other batch.The investigation carried out and the evaluation of the data provided did not reveal any evidence of a system related issue on either of the two systems.The investigation carried out and the evaluation of the data provided indicates possible preanalytical contamination.The data provided from swab tests on the instruments and the work area confirmed the contamination of the customer's work area, which has a high probability of inadvertently contaminating other samples.After decontamination of the suspected contaminated processing modules of both systems and the customer's work area, no further false positive results were reported by the customer.The instrument meets the manufacturer's operating specifications and is working as expected.The customer issue has been alleged on the cobas 8800 instrument, product code mza catalog number 05412722001 and udi (b)(4).The test used on the cobas 68/8800 system is the kit cobas 6800/8800 sars-cov-2 480t assay product code qjr, catalog number 09343733190 and udi (b)(4).This mdr is submitted against the kit cobas 6800/8800 sars-cov-2 480t (product code: qjr) instead of the the cobas 68/8800 system, per fda request.Added in b7 that no results were released outside of the laboratory.(b)(4).

• Brand Name: COBAS SARS-COV-2 TEST - 480T
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12029167
• MDR Text Key: 281539368
• Report Number: 2243471-2021-02029
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA200009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2021

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: 12/31/2021
• Device Catalogue Number: 09343733190
• Device Lot Number: G34336
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1