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 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 association de biologie praticienne (abp) survey organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit.Bacteroides fragilis was misidentified as bacteroides ureolyticus.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to a patient's state of health.No patient was directly associated with the abp survey result.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted with the patient isolate submitted by the customer.Testing performed: gram stain to confirm organism orientation; 16s sequencing; vitek® 2 anc id card (customer lot and random lot); vitek® ms; api® 20a strip; rapid id32a strip.Testing results: gram coloration indicates presence of coccobacillus, gram negative; 16s sequencing provided result of bacteroides fragilis; vitek® ms: bacteroides fragilis; rapid id 32a: bacteroides fragilis; api® 20a: bacteroides fragilis; vitek® 2 anc id card (both lots, customer and random) provided identification to bacteroides fragilis.The misidentification reported by the customer was not reproduced.The vitek® 2 anc id cards performed in accordance with specifications.

• 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5153769
• MDR Text Key: 28416100
• Report Number: 1950204-2015-00069
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Followup
• Report Date: 09/30/2015

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: 11/02/2015
• Device Catalogue Number: 21347
• Device Lot Number: 244324540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2014
• 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