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

Model Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux discrepant results associated with vitek® 2 anc test kit (reference 21347).The customer reported the vitek® 2 anc card results as anaerococcus prevotii but an alternative testing method vms results reported oligella urethralis.The customer reported that eleven (11) tests were run on the vitek® 2, ten (10) resulted in no identification and one (1) result was too noisy to give a result.The vitek® instrument was fine-tuned and the customer reported the system was not working as expected.The identification results were normal and anaerococcus species not present in the vitek® 2.The customer reported using another method.The reference method used was sequencing, genus used the same method as the vitek® 2 but not the same species name.The analysis of new data from the customer (data from new tests) with next vitek® 2, (which contains 3 species of anaerococcus : anaerococcus prevotii, anaerococcus tetradius, anaerococcus vaginalis), the customer reported that the results again anaerococcus tetradius for two (2) of the eleven (11) tests with kb v3.1 industry and kb v3.2 (next kb) and 1 of the 11 tests with kb v3.0 clinic.Culture submittals were requested by biomérieux.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux discrepant results associated with vitek® 2 anc test kit (reference (b)(4)).The customer submitted the strain for evaluation.An investigation was performed.The submitted strain was subcultured, and testing included anc cards from the customer's lot and a random lot, in duplicate, and 16s sequencing.All four anc cards tested resulted in excellent identifications of anaerococcus prevotii.16s sequencing gave the final identification of anaerococcus tetradius (99%).In conclusion, anaerococcus tetradius is not a species claimed by the vitek 2 anc card.The following limitation is stated in the vitek 2 product information concerning testing of unclaimed species: 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.The vitek® 2 anc test kit performed as expected.

• 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: 6529211
• MDR Text Key: 74023152
• Report Number: 1950204-2017-00132
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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 Model Number: 21347
• Device Lot Number: 244397720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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