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

Catalog Number 21341

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 the united states notified biomérieux of a misidentification associated with the vitek® 2 gram negative test kit (reference 21341) involving a urine sample.The customer reported the vitek® 2 gn test kit identified the organism as proteus hausari; however, the sample was sent to api who identified the sample as proteus vulgaris.There is no indication that incorrect results were reported and the customer did not report negative patient impact or adverse events associated with the discrepancy.Culture submittals were requested by biomérieux.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states reported the occurrence of a low discrimination identification of proteus penneri / proteus hauseri in association with the vitek® 2 gram-negative (gn) identification (id) test kit (card).The expected identification for this api® survey organism (api proficiency urine ur-11) was proteus vulgaris.Investigational testing api® survey organism included: - vitek® 2 gn id cards [two cards each for four (4) customer lots, one (1) random lot]: two (2) of the customer lots (4 cards total) provided a low discrimination call of proteus penneri / proteus hauseri.The remaining two (2) customer lots and the random lot (6 cards total) provided a low discrimination call of proteus penneri / proteus pneumotropica.- api® 20e: identified proteus vulgaris group.- vitek® ms: low discrimination call of proteus penneri / proteus vulgaris.As the organism is indole-positive, the vitek® ms call of proteus vulgaris would be correct.The investigation concluded the api® survey organism has an atypical biochemical profile for analysis by the vitek® 2 gn knowledge base.

• Brand Name: VITEK® 2 GRAM NEGATIVE TEST KIT
• Type of Device: VITEK® 2 GRAM NEGATIVE 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; st. louis, MO 63042
• MDR Report Key: 6228614
• MDR Text Key: 64052844
• Report Number: 1950204-2017-00006
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL 1 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241391440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1