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 Problem Non Reproducible Results (4029)

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

Event Date 11/10/2022

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 from ireland alleged discrepant results for a single patient while using the cobas sars-cov-2 nucleic acid test on the cobas 58/68/8800 systems.The alleged sample initially generated positive results for target 1 (sars-cov-2) and target 2 (pan-sarbecovirus).The same sample was repeated on another platform (taqpath covid-19 ce-ivd assay) generating sars-cov-2 negative result.The sample was repeated once again on the same cobas 6800 generating negative results for both targets.The results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.

Manufacturer Narrative

The root cause could not be established.However, the reason for the discrepancies observed by the customer is likely sample-specific.The data does not show any indication of a product problem or systemic issue.The differences in technology between the roche product and the non-roche product also should be taken into account and cannot be ruled out.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), product code: qjr).The product catalog number for the test (480t) is 09343733190 and the udi is (b)(4).

• 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: 15928757
• MDR Text Key: 308188831
• Report Number: 2243471-2022-01018
• Device Sequence Number: 1
• Product Code: QQX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K213804
• 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: 12/06/2022

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: 12/31/2022
• Device Catalogue Number: 09448870190
• Device Lot Number: H33956
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/06/2022
• 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