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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a discrepant organism identification in association with the vitek gram-negative (gn) identification (id) test kit.Vitek gn id result - staphylococcus hominis.Bruker mass spec (maldi-tof) - staphylococcus saprophyticus.It is not known which, if either, result was reported to the treating physician.However, there is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to the patient's state of health.Culture submittal was requested by biomerieux for internal investigation.Strains were destroyed by the customer and are therefore not available for submittal.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Internal biomérieux investigation was conducted.The customer did not comply with biomérieux's request for sample submittal.The customer provided one (1) vitek® 2 gp id lab report.The gp id lab report was reviewed for atypical reactions for staphylococcus saprophyticus.The atypical negative reactions present on the report indicate that the mcfarland density used was too light, the organism could have been too old or a non-recommended media was used.Since the strain was not submitted for testing, it is not possible to determine the cause of the misidentification.Evaluation of the manufacturing qc records indicates gp lot 242358010 passed on initial qc performance testing.There were no issues observed.The gp id card lot is performing in accordance with specifications.

• 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5275048
• MDR Text Key: 32984723
• Report Number: 1950204-2015-00118
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242358010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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