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 False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

Though the trc does not allow for quantification, the customer communicated that a sample near the limit of detected was suspected.Data was provided and evaluated.The data shows all curves were negative without any abnormal curves with robust ic curves, which indicates that it is unlikely inhibition or a reagent issue.The sample generated consistent negative results during 2 separate runs.The runs contain valid controls as well as positive and negative samples, which also indicates that a reagent problem is unlikely.The discrepant results observed are likely sample specific due to a sample near the lod of the test.Samples near the lod can waiver between positive and negative.Differences in technology also cannot be ruled out as a contributing factor.No product problem was identified.It can be concluded that the discrepant results are related to sample specific factors.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).

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 one patient when using the cobas sars-cov-2 qualitative assay for use on the cobas 5800/6800/8800 systems.The patient first tested negative using the trc test.A new same sample was collected and tested on cobas 5800 twice and yielded a negative result for sars-cov-2 each time.All results were reported to the medical personnel.No harm is alleged.An investigation was conducted to evaluate the customer¿s allegation.Per fda¿s eua guidance, 1 mdr will be filed.

• 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: 15447137
• MDR Text Key: 306074712
• Report Number: 2243471-2022-00793
• 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
• Report Date: 09/19/2022

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: 10/31/2022
• Device Catalogue Number: 09448870190
• Device Lot Number: H31078
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/19/2022
• 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