MAUDE Adverse Event Report: BIOMERIEUX SA THXID BRAF; THXID¿ BRAF

Catalog Number 410697

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in united states notified biomérieux of a product problem when using the thxid braf product.The customer reported after dilution of the positive control with 150 l as specified in the protocol, the nano drop quantity is around 2 ng/ l and the assay failed with an invalid positive control.The customer reported diluting the positive control with less volume (50 l), the nano drop reading is around 7 ng/ l.The assay did function correctly with a higher concentrated positive control.Due to the repeat testing before using another assay, the customer indicated a delay in reporting results.There is no indication or report from the customer that the product problem led to any adverse event related to the patient's state of health.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: several tests were performed internally in order to check the performance of the product.A total of (b)(4) pc were tested and the results were within the expected specifications.Also, customer returned samples were analyzed and during the investigation it was noted that there was no fluorescence for both runs and for both targets (v600e and v600k) which is rare for the internal control.The discrepancy observed by the customer is likely due to handling or equipment used by the customer.It is recommended that the customer consult with the biomérieux local representative regarding handling steps described in the instruction for use, especially: - after addition of 150 ¿l of positive control diluent to the positive control sphere, mix at full speed using a vortex-type mixer until a clear solution has been obtained.- after addition of the 2 ¿l of positive control: several aspiration/dispensing with the pipette are necessary to allow a good homogenization of the pc in the mix.We advise to count a minimum of 5 aspiration/dispensing.Since the root cause of the discrepancy is related to use error no corrective action is warranted at this time.

• Brand Name: THXID BRAF
• Type of Device: THXID¿ BRAF
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6211049
• MDR Text Key: 63621005
• Report Number: 3002769706-2016-00533
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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 Catalogue Number: 410697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1