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 Consequences Or Impact To Patient (2199)

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 2 gram-positive (gp) identification (id) test kit.Staphylococcus aureus was misidentified as staphylococcus chromogenes.Vitek 2 gp id testing was repeated twice with the same staphylococcus chromogenes result.The microbiologist decided to report this organism as a staphylococcus aureus.The vitek 2 gp id result was not reported to the physician nor used in any patient treatment decisions.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 a patient's state of health.Culture submittal was requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was conducted.The customer did not comply with biomérieux request for patient isolate or raw data to be sent to the manufacturing site for evaluation.Six patient lab reports were submitted by the customer.Review of each lab report reveals several atypical negative reactions as compared to expected reactions for staphylococcus aureus.An increase in atypical negative reactions can indicate a deviation from the recommended set up procedure or a strain that is not very viable.The strain itself may also be atypical for testing via rapid ast method (e.G.Vitek 2).Without the strains and raw data, it is not possible to determine the cause of the mis-identification.The isolate was tested by the biomérieux (b)(4), and the organism misidentification was not reproduced.Evaluation of the manufacturing qc batch records indicates the vitek 2 gp id card lot passed on initial qc performance testing.No issues were observed.The vitek 2 gp id cards are performing in accordance with specification.

• 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: 5246467
• MDR Text Key: 32023967
• Report Number: 1950204-2015-00107
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/18/2015

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: 12/19/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242365810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2015
• 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