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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Biomérieux investigation was conducted.The customer's cap strain was not submitted so the internal lyophilized cap sample was reconstituted and tested.The reconstituted sample was subcultured, and vitek® 2 gp id testing included two cards from the customer lot and two cards each from three random lots (total of eight cards).Excellent identification of pediococcus acidilactici were obtained on four cards from random lots.The two cards from the customer's lot and two cards from random lots resulted in low discrimination calls of pediococcus acidilactici/pediococcus pentosaceus.The low discrimination identification results are acceptable since they include the expected result of pediococcus acidilactici.These species are closely related and review of the expected data for pediococcus acidilactici demonstrated no atypical reactions.The investigation concluded the vitek® 2 gp id is performing as expected.Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of cap survey organism pediococcus acidilactici as pediococcus pentosaceus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat testing provided the same result.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey sample.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation was initiated.

• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6000078
• MDR Text Key: 56494144
• Report Number: 1950204-2016-00143
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242395010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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