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 the united states contacted biomérieux 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 caprae.Repeat testing yielded the same result.The customer sent the isolate to a reference laboratory for confirmatory testing.The reference laboratory returned an organism identification of staphylococcus aureus; test method was mass spectometry.The reference laboratory also performed ast testing and determined the organism is (b)(6).The customer indicates the discrepant result did not lead to any adverse event related to a patient's state of health.Culture submittal was requested by biomérieux for internal investigation.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was conducted.However, the strain and raw data were not submitted by the customer.The lab report showed four (4) atypical negative reactions (nag, sac, mbdg & aglu) for staphylococcus aureus.It's not possible to further evaluate the cause of the atypical reactions without the strain and/or raw data.Evaluation of the manufacturing qc batch records for gp id lot 242362910 indicates the lot passed qc performance testing.Review of complaint records does not indicate a trend or increase in reports of vitek 2 gp id misidentification of staphylococcus aureus.Based on the investigation results, the vitek 2 gp id test kits are 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: 5380186
• MDR Text Key: 36482830
• Report Number: 1950204-2016-00008
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/02/2015

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: 11/20/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242362910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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