MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT; VITEK® 2 GN ID TEST KIT

Catalog Number 21341

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of a non-salmonella organism as salmonella in association with the vitek® 2 gram-negative (gn) identification (id) test kit.The salmonella result was reported to the physician as presumptive.Upon receipt of a salmonella organism identification, the customer sent the isolate to the state lab for confirmatory testing.The state lab returned a response of "not salmonella." the customer repeated the testing via vitek® 2 gn id, and obtained a result of escherichia coli.The customer stated the discrepant result did not impact patient therapy; there was no adverse impact to the patient's state of health.Culture submittal may be requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states contacted biomérieux to report a misidentification of a non-salmonella organism as salmonella in association with the vitek® 2 gram-negative (gn) identification (id) test kit.An internal biomérieux investigation was performed.The submitted isolate was subcultured and testing included vitek® 2 gn cards from the customer's lot and a random lot, in duplicate, and the api® 20e test kit.All four (4) cards tested resulted in very good identifications of escherichia coli.The api® kit resulted in an excellent identification of escherichia coli ((b)(4)).The customer's biochemical reactions for the salmonella spp.Identification are not available for review.It should be noted, when an identification of salmonella is made by vitek® 2 gn cards, an analysis message of "confirm by serological tests" is given.Vitek® 2 gn cards are performing as expected.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN 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: 6363841
• MDR Text Key: 68535754
• Report Number: 1950204-2017-00073
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/26/2017
• Device Catalogue Number: 21341
• Device Lot Number: 2410000203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2016
• 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