MAUDE Adverse Event Report: BIOMERIEUX VITEK CARD

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/03/2017

Event Type  malfunction  

Event Description

(b)(6) discovered there was a packaging defect with vitek cards from biomerieux.Biomerieux changed their packaging had holes which appeared to be caused by the crimping of the packaging material at the mfr's factory.This defect was noticed after a few organisms were reported as highly resistent, but upon repeat testing requested by our infectious disease team, these organisms were shown to be very susceptible.

• Brand Name: VITEK CARD
• Type of Device: VITEK CARD
• Manufacturer (Section D): BIOMERIEUX
• MDR Report Key: 6541186
• MDR Text Key: 74407774
• Report Number: MW5069533
• Device Sequence Number: 1
• Product Code: NGZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1