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

Catalog Number 21342

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in the united states contacted biomérieux to report a misidentification of streptococcus pyogenes in association with the vitek® 2 gp id test kit.The customer stated results were inconsistent and included streptococcus agalactiae, streptococcus dysgalactiae ssp dysgalactiae, and low discrimination between streptococcus dysgalactiae ssp dysgalactiae and streptococcus suis.The organism identification to streptococcus pyogenes (group a) was obtained via offline serotyping.There is no indication or report from the laboratory or physician that the discrepant result(s) led to any adverse event related to the patient's state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A us customer reported a misidentification of a gram positive organism with the vitek® 2 gp card.The organism was tested three time and the results were streptococcus dysgalactiae ssp dysgalactiae, s.Agalactiae and unidentified organism.Serotyping identified the organism as a group a streptococcus.The customer submitted the isolate for evaluation.A biomérieux investigation was performed.The organism was subbed and tested on both the customer lot and a random lot of vitek 2 gp cards, in duplicate.Vitek® ms was also performed.On all four (4) cards tested, a very good id (95%) of s.Pyogenes was obtained.Vitek ms also identified the organism as s.Pyogenes, with a 99.0% confidence value.A comparison of customer card reaction results for s.Dysgalactiae ssp dysgalactiae against expected reaction results for s.Pyogenes showed five (5) atypical negative reactions (bgurr, bgur, baci, draf, pul).A comparison of customer card reaction results for s.Agalactiae against expected results for s.Pyogenes showed three (3) atypical positive (bgurr, bgur, draf) and three (3) atypical negative (appa, aglu, tyra) reactions.A comparison of customer card reaction results for the unidentified organism call against expected reaction results for s.Pyogenes showed five (5) atypical positive reactions (bgurr, bgur, baci, nc6.5, pul).An increased number of atypical reactions can indicate a strain with decreased viability, contamination, mixed culture, use of non-recommended media or other user set up error.Vitek 2 gp cards are performing as expected and no further action is necessary.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7596394
• MDR Text Key: 112046590
• Report Number: 1950204-2018-00223
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• 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,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420427403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• 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