MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANC TEST KIT

Catalog Number 21347

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer notified biomerieux of a mis-identification when using the vitek 2 anc test kit.An atcc quality control sample of clostridium septicum (atcc 12464) was run and gave the results of dglu+, bman+, mte+, and ops-.The expected results are dglu-, bman-, mte-, and ops+.When specifically asked the customer noted no injury or death happened as a result of this incident.An investigation has been initiated by biomerieux to investigate this event.

Manufacturer Narrative

An investigation into a product issue while using the vitek® anc test kit was performed.The customer reported discrepant results with a qc sample.Testing was performed on 4 anc cards (customer lot twice: 244379420 and random lot twice: 244366910 on cba in an anaerobic atmosphere) on each strain tested, both the customer and an internal reference strain.The customer strain was tested.The discrepant results were duplicated.When the internal reference strain was tested, the results were as expected.Qc was conforming in-house with all lots tested whatever the media used for the internal reference strain.Therefore, the most likely cause of this event is a degraded strain from the customer.Anc cards performed as intended and no further action is required.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC TEST KIT
• 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: 5851691
• MDR Text Key: 51348354
• Report Number: 1950204-2016-00085
• 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: Initial,Followup
• Report Date: 07/04/2016

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: 05/04/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244379420
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1