MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of atcc baa-750staphylococcus saprophyticus as aerococcus viridans or staphylococcus lentus in association with the vitek 2 gram-positive (gp) identification (id) test kit.Repeat test obtained the same result.When asked about their preparation process for the qc organism, the customer stated they purchase a strain and sub-culture it to a media plate.After one week, they use the organism growth on this plate to sub-culture a second plate.This is repeated a third time; they perform testing from the organism growth on this third plate.This method deviates from that in the instructions for use (ifu).There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the atcc strain.Culture submittal was requested by biomerieux for internal investigation.Biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of atcc® baa-750¿ staphylococcus saprophyticus as aerococcus viridans or staphylococcus lentus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.An internal biomérieux investigation was performed.The submitted customer's qc strain and the in-house qc strain were subcultured and tested on two (2) cards from two (2) gp card lots.The lot number tested by the customer, 2420015103, was not available in storage.The eight (8) cards tested on these strains all gave the expected negative amy, draf, and dsor reactions.The customer did not submit archived data so it was not possible to determine what may have caused the qc deviation.Vitek® 2 gp cards are performing as expected and no further action is required.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID 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: 5998388
• MDR Text Key: 56451204
• Report Number: 1950204-2016-00142
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K952095
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2017
• Device Catalogue Number: 21342
• Device Lot Number: 2420015103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2016
• 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