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

Catalog Number 21342

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation into the mis-identification event was investigated by biomerieux.The reconstituted cap survey sample was tested on 2 cards from 4 different lots.Excellent identifications of pediococcus acidilactici were obtained on four cards and low discrimination calls of pediococcus acidilactici/pediococcus pentosaceus were obtained on the remaining four cards.These species are closely related and review of the expected data for pediococcus acidilactici demonstrated no atypical reactions.Based on the results of the investigation, the product is operating within specifications.

Event Description

A customer notified biomerieux that they had a mis-identification when using the vitek 2 gp id test kit.A cap survey proficiency sample was identified by the vitek 2 tesk kit as pediococcus pentosaceus.The actual result should have been pediococcus acidilacticl.Since this is a proficiency sample and not a patient sample, no injury or death associated with this event.An investigation has been conducted by biomerieux for event.

• Brand Name: VITEK® 2 GP ID TEST KIT
• Type of Device: VITEK® 2 GP 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: 6031319
• MDR Text Key: 57560780
• Report Number: 1950204-2016-00148
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• 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
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242397440
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1