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

Catalog Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of proponobacterium acnes in association with the vitek® 2 anc test kit.The customer reported the results received on vitek® 2 to be atobopium vaginae but expected the result to be proponobacterium acnes.The customer sent the strain to au chu de bordeaux but no results were obtained on malditoff brucker, although results were obtained by sequencing arn16s: proponiobacterium acnes.The customer reported that the incorrect results were not reported to a physician and did not impact patient results or treatment.There was a delay in reporting results.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from france reported to biomérieux a misidentification of proponobacterium acnes in association with the vitek® 2 anc test kit.(b)(4).The customer submitted lab reports for evaluation.An investigation was performed.The customer set up the anc card from a 24 hour culture grown on columbia sheep blood agar under anaerobic conditions.Two anc lab reports were submitted showing an excellent identification of atobopium vaginae.Both lab reports showed two atypical negative reactions (ellm, arg) for an identification of proponobacterium acnes according to the anc knowledge base.Three lab reports were submitted for the quality control strain, corynebacterium striatum atcc baa-1293, which showed passing qc results.A review of quality records confirmed anc lot 244097720 had no issues with qc performance testing and met final qc release criteria.In conclusion, 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.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6352237
• MDR Text Key: 68281131
• Report Number: 1950204-2017-00062
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244397720
• Other Device ID Number: 03573026144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1