MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 AST-N284 TEST KIT

Catalog Number 414711

Device Problems False Negative Result (1225); Device Packaging Compromised (2916)

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

Event Date 07/02/2015

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a quality control (qc) failure in association with the vitek 2gram-negative antimicrobial susceptibility test ast-n284 card (ref 414711, lot 704334120).The laboratory did not release any results associated with ast-n284 cards; the customer used disc method to obtain/report results.Customer evaluation identified damaged card packaging (foil pouch punctured).Repeat testing was performed in the hospital laboratory using ast-n284 cards from damaged pouches and from intact pouches; qc failure was associated only with cards from damaged pouches.As clinical antibiotic treatment occurs prior to any laboratory ast testing/reporting, there was no clinical therapy delay or misdiagnosis in this case.In addition, qc acceptance and ast-n284 reporting resumed within 24 hours.There is no indication or report from the hospital or treating physician to biomerieux that the qc failure led to any adverse event related to the patient's state of health.There is no reported negative impact on the patient.Vitek 2 ast-n284 cards and associated damaged pouches have been requested by biomerieux for internal investigation.

Manufacturer Narrative

The vitek® 2 systems product information manual instructs customers to not use the card if the protective package is damaged.The customer submitted 23 pouches and one carton for evaluation.All 23 returned pouches exhibited damage to and/or punctures in the pouch.All returned pouches were packaged using the same card poucher during the same timeframe.The submitted carton exhibited a large crease along one edge indicating this box may have been smashed or dropped.The appearance of the damage/punctures for all defective pouches indicate that the pouch material is pushed outward from the inside of the pouch.This is not consistent with pouch defects caused by the pouching equipment, which are characterized by material that is pushed inward from the outside of the pouch.Although the root cause of these defective pouches is unknown, the most likely source is that the impacted boxes were not handled properly.This damage could have occurred at any time from the time the cards were placed into cartons at the card poucher to the time the box was opened by the customer.These defects are not caused by mechanical contact from the card poucher.The absence of pouch integrity violations in the qc samples and product retains and a review of the production records of this lot suggests this was an isolated incident and not indicative of a systemic problem.

• Brand Name: VITEK 2 AST-N284 TEST KIT
• Type of Device: VITEK 2 AST-N284 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4908656
• MDR Text Key: 22522301
• Report Number: 1950204-2015-00014
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K080107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2016
• Device Catalogue Number: 414711
• Device Lot Number: 704334120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Date Device Manufactured: 08/07/2014
• 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