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) contacted biomerieux to report a discrepant cap survey organism (mbt-2015b) identification on the vitek 2 gram-positive (gp) identification (id) test kit (ref 21342).The gp id test kit reported the organism as streptococcus pseudoporcinus when it should have been streptococcus mitis.Repeat testing yielded the same result.There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to a patient's state of health.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The gram-positive knowledge base uses seven (7) tests (dxyl, phos, dsor, lac, dman, dtre, adh2s) to distinguish between streptococcus mitis and streptococcus pseudoporcinus.Six (6) of these tests are positive for streptococcus pseudoporcinus.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors.However without the strain, lab reports, raw data or gp id card lot number it is not possible to further evaluate the cause of the misidentification.

• 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: 5267871
• MDR Text Key: 32706277
• Report Number: 1950204-2015-00115
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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 Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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