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 Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a discrepant neqas organism identification in association with the vitek 2 gram-positive (gp) identification (id) test kit.Staphylococcus epidermidis was misidentified as staphylococcus hominis.Initial testing was performed by the customer (b)(6), 2015.In october, upon receiving notification from neqas that the identification was incorrect, the customer prepared a new culture from the original strain and retested twice.Retesting occurred (b)(6).Results obtained were low discrimination, s.Epidermidis / s.Hominis s.Epidermidis.Culture submittal was requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was conducted.Tests performed against the organism submitted by the customer included: 16s sequencing id32staph strip vitek ms vitek 2 gp id card (customer lot 242354910 and a random lot 242346440) results: 16s sequencing gave an identification to staphylococcus epidermidis (100%).Vitek ms: staphylococcus epidermidis 99.9%.Id32staph: staphylococcus epidermidis 1 (57%) and staphylococcus epidermidis 2 (37.8%) vitek 2 gave identification to the species staphylococcus hominis ssp hominis for both lots tested.The investigation reproduced the misidentification to the species staphylococcus hominis ssp hominis observed by the customer using vitek gp id cards (customer lot 242354910 and random lot 242346440).The investigation confirmed the identification expected by neqas as the species staphylococcus epidermidis with the reference method (16s sequencing) and alternative methods (id32staph and vitek ms).The investigation concluded that the patient isolate is an atypical strain for vitek 2 system phenotypic ast testing method, which is colorimetric and measures organism growth behavior.Genetic measurement techniques (16s sequencing and vitek ms) and non-automated methods such as id32staph are more conducive to testing certain slower-growth organisms.For any organism placed into a vitek 2 test card, the vitek 2 system will assess the card readings against the known organisms and provide an organism identification, if possible, based on a combination of growth well reactions.For results with a percent confidence of <99%, the customer must make a determination of acceptance or further testing based on the logical likelihood of the identification considering other laboratory and clinical factors.

• 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: 5204793
• MDR Text Key: 30523855
• Report Number: 1950204-2015-00090
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/03/2015

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: 09/01/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242354910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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