MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD

Catalog Number 21347

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in france contacted biomerieux to report a misidentification of bacteroides ovatus (microbiologics atcc 1296) as prevotella disiens in association with the vitek 2anc id test kit.Per microbiologics (mbl) recommendation, the strain was incubated using cos media in an anaerobic atmosphere and obtained colony growth after 48 hours.There is no report from the customer that the occurrence lead to any adverse event related to any patient's state of health.Culture submittals were requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer france reported a misidentification of bacteroides ovatus (microbiologics atcc® baa-1296) as prevotella disiens in association with the vitek® 2 anc id test kit.There were 3-15 negative (-) well reactions associated with the misidentifications.Biomérieux investigation was conducted.Using the internal reference strain of atcc® baa-1296 as well as the strain submitted by the customer, investigational testing was performed from cultures incubated on cba plates, in anaerobic environment, for two different incubation times (24 and 48 hours).Internal reference strain produced the expected result of bacteroides ovatus for isolates from both incubation times.Customer strain produced expected result of bacteroides ovatus for one test, and produced three (3) discrepant well reactions (+) for the second test.The investigation did not duplicate the customer results, but obtained one time, three (3) discrepant positive (+) well reactions ((b)(4)) with the customer strain, on the random anc id lot (244390210).Anc id test kit lot 244366910 met final qc release criteria.There were no issues observed on qc performance testing.There were no ncmr's written against this lot.Ncmr's were reviewed for the last 13 months and there were no ncmr's written for misidentification of atcc baa-1296 bacteroides ovatus.The investigation concluded the vitek® 2 anc id test kit is performing as intended.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 ANC CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5885945
• MDR Text Key: 52726643
• Report Number: 1950204-2016-00099
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• 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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2016
• Device Catalogue Number: 21347
• Device Lot Number: 244366910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1