MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK® MS

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of aerococcus sanguinicola as listeria grayii, for a gram positive urine sample, in association with vitek® ms.The isolate was cultured on anc media and tested twice with vitek® ms.The identifications produced were coryne /listeria/geobacillus and then listeria/geobacillus/gemella.The isolate was also cultured on cos media and tested four times with vitek® ms which gave a result of listeria grayi.The customer also tested the isolate with vitek® 2, and the results were no identification and anaerococcus prevotii.The customer sent the strain to an external laboratory and the result was aerococcus sangunis by maldi-tof.The customer reported that the incorrect results were not reported to a physician and patient results and treatment were not affected.There was a delay of 10 days for reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from france reported to biomérieux a misidentification of aerococcus sanguinicola as listeria grayii, for a gram positive urine sample, in association with vitek® ms (udi (b)(4)).An investigation was performed.Fine tuning was not required when the misidentification occurred.The expected species (aerococcus sanguinicola) is not included in the vitek® ms database v2.0 as used by the customer.The vitek® ms system identification is based on a species pattern classification.When the microorganism tested is not part of the database, no specific species pattern will be available in the database for comparison.Consequently, the system can give: - no identification (most probable answer) when the spectrum acquired does not match with any species pattern.- a low discrimination identification (often the same genus than expected) when the spectrum acquired presents high level of similarity with multiple specific species patterns present in the database.- an incorrect single choice identification to the nearest pattern species (often same genus than expected) when the spectrum acquired presents high level of similarity with a specific species pattern present in the database.Fsca 3305 has been published in february 2017 in order to inform the customers about knowledge base limitations.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6400401
• MDR Text Key: 69871114
• Report Number: 3002769706-2017-00049
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1