MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE ID TEST KIT

Catalog Number 21341

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer notified biomerieux of a mis-identification when using the vitek 2 gram negative id test kit.The vitek 2 test kit identified the organism as rhizobium radiobacter.Confirmatory testing identified the organism as acinetobacter.When specifically asked the customer noted no injury or death happened as a result of this incident.The customer did indicate a delay in results of greater than 24 hours as a result of this event.An investigation has been initiated by biomerieux to investigate this event.

Manufacturer Narrative

An investigation into a mis-identification event while using the vitek® gn test kit was performed.The customer obtained a result of acinetobacter sp.As rhizobium radiobacter.The customer returned the patient strain involved in this event.Testing by vitek® ms and id32gn confirmed the organism to be acinetobacter johnsonii.It is to be noted that acinetobacter johnsonii is not within the knowledge base of the gram negative test kit on vitek® 2.The customer strain was tested on retain samples from lots 241377140, 241377540, and 242383840.Lots 241377140 and 241377540 were customer lots involved in this event and lot 242383840 is a random lot.Results from this testing was a low discrimination between acinetobacter lwoffi and neisseria animaloris/zoodegmatis.The misidentification observed by the customer was not duplicated.Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.

• Brand Name: VITEK® 2 GRAM NEGATIVE ID TEST KIT
• Type of Device: VITEK® 2 GRAM NEGATIVE ID TEST KIT
• 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: 5854477
• MDR Text Key: 51457481
• Report Number: 1950204-2016-00088
• Device Sequence Number: 1
• Product Code: LRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962609
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241377140
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1