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

Catalog Number 21347

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

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A pharmaceutical customer in (b)(6) contacted biomerieux to report a misidentification of corynebacterium imitans as corynebacterium diphtheriae in association with the vitek 2 anc identification (id) test kit.Repeat testing obtained the same results.Alternate method testing microseqid (molecular) obtained the corynebacterium imitans result.The customer stated the discrepant anc id results were not reported to the physician; therefore, these results did not affect patient treatment.Culture submittal was requested from the customer; the isolate is no longer available.Biomerieux investigation will be initiated.

Manufacturer Narrative

A pharmaceutical customer in (b)(6) contacted biomérieux to report a misidentification of corynebacterium imitans as corynebacterium diphtheriae in association with the vitek® 2 anc identification (id) test kit.An internal biomérieux investigation was performed.The vitek® 2 anc card does not claim c.Imitans.The following limitation appears in the product labeling: newly described or rare species may not be included in the anc database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification.It should also be noted that the proper incubation temperature for testing in the vitek® 2 anc card is 35-37c.On 21nov2016 industrialization vitek® 2 anc lot 244394540 met final qc release criteria.There were no issues observed on initial qc performance testing.

• Brand Name: VITEK® 2 ANC ID TEST KIT
• Type of Device: VITEK® 2 ANC ID 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: 6078541
• MDR Text Key: 59225849
• Report Number: 1950204-2016-00164
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/02/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244394540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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