MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

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 (b)(6) reported a misidentification of a biologie prospective survey specimen (bacterio.2015-3a - propionobacterium acnes) as kocuria rosae in association with the vitek 2 gp id card.Though the instructions for use (vitek 2 product information manual) indicate the vitek 2 anc id card is the appropriate card for use with anaerobic organisms, the customer performed testing via vitek 2 gp id card.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.No patient was directly associated with the (b)(6) proficiency result.Proficiency organism submittal has been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The results in the gp id card showed the strain was positive for only the (b)(4) well in the gp id card and all other tests/reactions were negative.Propionobacterium acnes is an anaerobic species.Anaerobic species are not claimed in the vitek® 2 gp id knowledge base, and should be tested in the vitek® 2 anc id card.In addition, the gram stain of propionobacterium acnes shows pleomorphic, branching gram positive bacilli resembling corynebacteria (also claimed by the anc id card and not the gp id card).The customer chose the incorrect card to test the strain.Based on the behavior and characteristics of the strain, selection of the vitek® 2 gp id was inappropriate and constitutes off-label use.The investigation concluded that the vitek® 2 gp id test kit did not malfunction and is performing as intended in accordance with product specifications.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5198705
• MDR Text Key: 30299382
• Report Number: 1950204-2015-00089
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952095
• 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: 10/30/2015

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: 08/10/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242352710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• 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