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

Catalog Number 09175431190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

The assay is working as intended.The issue alleged by the customer is most likely due to the samples being near or below the lod of the assay.Additionally, the complaint kit lot was tested and results met specifications.(b)(4).

Event Description

The agency has clarified its expectation that manufacturers of emergency use authorization (eua) products for sars-cov-2 diagnostic tests report allegations of false positive or false negative results independent of harm or malfunction or off-label use beyond 803s "reasonably suggests" requirements.Accordingly, we have performed a retrospective review of cases to determine whether to report any additional cases.A customer from (b)(6) alleged discrepant results with the cobas¿ sars-cov-2 assay.A review of the provided data confirmed that sample id (b)(6) generated a positive result for target 1 with a ct value of 36.5 and negative for target 2 and ic ct of 33.17.No harm or injury was indicated.A review of the positive growth curves showed a very flat curve with a late rise in fluorescence corresponding with the late ct values.Additionally, the ic does not appear to be delayed.The alleged runs contained valid roche controls and are in line with release data.The sample was retested with the cobas¿ sars-cov-2, cepheid, and altona realstar assays and all were negative.The retest data on the cobas¿ sars-cov-2 was not available to be provided.Information is not available regarding whether any of the results were reported to the patient.The customer confirmed that the assay was used for screening purposes.The samples were nasopharyngeal swabs collected in a utm collection media tube.The late ct value of 36.5 for target 1 is indicative of a sample near or below the limit of detection (lod) of the assay.As per table: lod determination using usa-wa1/2020 strain in the method sheet this would correspond to a hit rate of less than 38.1%.As such, results can waiver between positive and negative as observed here with the alleged samples.According to the instructions for use, the cobas sars-cov-2 for use on the cobas 6800/8800 systems is a real-time rt-pcr test intended for the qualitative detection of nucleic acids from sars-cov-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet covid-19 clinical and/or epidemiological criteria.The cobas sars-cov-2 is a qualitative test for use on the cobas 6800/8800 system for the detection of the 2019 novel coronavirus(sars-cov-2) rna in nasal, nasopharyngeal, and oropharyngeal swab samples collected in copan universal transport medium system (utm-rt),bd universal viral transport system (uvt), cobas pcr media, or 0.9% physiological saline.Based on the totality of the information and data provided, the assay is working as intended.

• Brand Name: COBAS SARS-COV-2 TEST
• 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: 10760389
• MDR Text Key: 250175331
• Report Number: 2243471-2020-00266
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EUA200009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 09175431190
• Device Lot Number: G11392
• Date Manufacturer Received: 09/02/2020
• 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