MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS COBAS MRSA/SA TEST FOR USE ON THE COBAS 4800 SYSTEM; NUCLEIC ACID TEST FOR DETECTION OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS

Catalog Number 06768172190

Device Problem False Negative Result (1225)

Patient Problem Staphylococcus Aureus (2058)

Event Date 02/19/2015

Event Type  No Answer Provided  

Event Description

A customer site in (b)(6) filed a complaint alleging that (b)(6) results for one sample were generated with the cobas (b)(6) test for use on the cobas 4800 system ivd.The sequence type was stated to be st398.All run controls were valid and the ic ct values were within the predefined ranges for the test.The sample was culture positive for (b)(6).It was also stated that the results were negative with the bd-max test.

Manufacturer Narrative

A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing.The outcome of this investigation will be communicated through a follow-up report.(b)(4).

Manufacturer Narrative

Date of report 07/31/2015.Date received by manufacturer 07/31/2015.Follow up report 1.Additional information / device evaluation.Device evaluated by manufacturer yes.(b)(4) a customer from germany alleged that a (b)(6) while using the cobas mrsa/sa test.The customer requested information on if our assay detected st398 ((b)(6)).A sample testing in (b)(6) 2015 generated (b)(6) but was (b)(6) when testing by cobas 4800 and bd-max platforms.Additional testing was performed in which a (b)(6) was generated as well the run data was provided and evaluated.The data shows that the cobas 4800 reagents are working as expected; all controls including the internal control (ic) are valid.The sample did generate robust curves for sa and ic which shows that the sample contains the necessary amount of nucleic acids needed to perform and generate reliable results with the cobas mrsa test.Also note that within the same run as the sample in question, there are properly identified (b)(6) samples.The (b)(6) sequence type (st) 398 is known to be associated with livestock but has been documented to infect humans as well at a lower prevalence.The cobas mrsa/sa test can detect some isolates associated with st398 but not all.The alleged (b)(6) that is being observed by the customer is most likely sample related.Please note that the sample type used during testing within the current case was off-label.A mix sample collected from the nose, throat, and perineum is not a validated sample type for the cobas mrsa/sa test.Samples were provided for sequencing.Two samples were provided: the original copan e swab and swab from culture.The sequencing results are inconclusive, as a complete sequence has not been able to be obtained.The re type cannot be verified sequence analysis due to the lack of upstream binding region for the assay oligos.Without the re type it cannot be determined why the sample in question was not detected by the cobas mrsa/sa test, but is likely a sample specific issue.Retain kit testing results met specification and the customer allegation was not observed.There is no indication of a product malfunction.(b)(4).

• Brand Name: COBAS MRSA/SA TEST FOR USE ON THE COBAS 4800 SYSTEM
• Type of Device: NUCLEIC ACID TEST FOR DETECTION OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS; 1080 us hw 202s; branchburg NJ 08876 373
• Manufacturer Contact: vincent stagnitto ; 1080 us hwy 202s; branchburg, NJ 08876-3733 ; 9082537569
• MDR Report Key: 4769889
• MDR Text Key: 5791991
• Report Number: 2243471-2015-00004
• Device Sequence Number: 1
• Product Code: NQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2015

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: 10/31/2015
• Device Catalogue Number: 06768172190
• Device Lot Number: T04206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR