MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD

Catalog Number 21347

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

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of proprionibacterium acnes as atopium vaginae in association with the vitek 2 anc id test kit.The customer performed confirmatory testing via rapidana and obtained the result of proprionibacterium acnes.Proprionibacterium acnes was reported to the physician.The customer reported a delay (unknown duration) as a result of the retesting.There is no report from the hospital or treating physician that the occurrence lead to any adverse event related to the patient's state of health.Culture submittals were requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of propionibacterium acnes as atopobium vaginae in association with the vitek 2 anc id test kit.An internal biomérieux investigation was performed.The customer tested the isolate from brucella agar (oxoid) after incubating the strain for 18-72 hr under anaerobic conditions.Two (2) lab reports were submitted; both showing an excellent identification of atopobium vaginae.Lab report (b)(6) showed two (2) atypical reactions (ellm negative and nag positive).Lab report (b)(6) showed three (3) atypical negative reactions (ellm, phea, amani).An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.On 01nov2016 ind/qc anc lot 244386840 met final qc release criteria.There were no issues observed on initial qc performance testing.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 ANC 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: 5883802
• MDR Text Key: 52393195
• Report Number: 1950204-2016-00097
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910666
• 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: 07/19/2016

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: 07/17/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244386840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2016
• 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