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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Biomérieux internal investigations were conducted for events #1 and #2.For event #3, investigation results are pending.Event #1 and event #2: on the abp qc survey, strain br1, we confirmed the identification expected to trueperella pyogenes with vitek® ms (ivd v2.0 ) and api coryne.We obtained on anc cards (customer lot + random lot), a low discriminated profile between trueperella pyogenes and actinomyces odontolyticus with 2 tests against / species.Atypical biochemical profile of the strain lead to a low level of identification on anc card.It is recommended in this case to perform complementary test to conclude.We did not duplicate the misidentification obtained by customer.We observed that internal biochemical profile is similar except for 2 tests borderline (+) instead of positive, more in favor of trueperella pyogenes.The anc cards are performing as expected and no further action is required.

Event Description

This report summarizes 3 malfunction events.(b)(4).A review of events indicated that testing via vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit resulted in organism misidentifications to include: actinomyces odontolyticus instead of trueperella pyogenes involving a quality control sample.Actinomyces odontolyticus instead of trueperella pyogenes involving a quality control sample.Corynebacterium minutissimum instead of corynebacterium diphtheria involving a patient sample.For all three (3) events, there was no indication or report of adverse events or negative patient due to the discrepant results.For events #1 and #2, the customers indicated the strains were not available for submittal and for event #3, the isolate was requested.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states reported an occurrence of a misidentification of corynebacterium diphtheria as corynebacterium minutissimum in association with the vitek® 2 anc id test kit.Biomérieux investigation was conducted.Testing of the isolate included one (1) anc id card from the same lot tested by the customer and one (1) anc id card from a random lot.Both anc id cards provided an organism identification of corynebacterium minutissimum.Since the centers for disease control (cdc) determined the organism to be corynebacterium diphtheria, no further internal testing was performed.Review of the internal raw data against the expected reactions for corynebacterium diphtheriae show there to be two (2) atypical negative reactions (ellm, mte) which contributed to the misidentification.The overall investigation concluded the submitted strain exhibits atypical growth behavior for the vitek® 2 anc id testing method.Device not returned to manufacturer.

• 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: 5828863
• MDR Text Key: 50624926
• Report Number: 1950204-2016-00071
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

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: 09/10/2016
• Device Catalogue Number: 21347
• Device Lot Number: 244355810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• 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
• Patient Outcome(s): Life Threatening