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

Event Description

A customer in (b)(6) notified biomerieux of a misidentification associated with vitek 2 gp test kit reference (b)(6).The customer reported getting an identification result of staphylococcus aureus 99% when they applied cns.The customer would not provide any additional information.

Manufacturer Narrative

This report was initially submitted due to vitek® 2 gp id misidentification of a coagulase negative staphylococcus (cns) as staphylococcus aureus.Biomérieux investigation was conducted.However, the customer did not comply with biomérieux request for lab report, raw data or patient isolate/strain.Evaluation of the manufacturing batch records for vitek® 2 gp id lot 242390310 indicated the lot passed on initial qc performance testing.There were no issues observed.Without the strain, lab reports or raw data, no further investigation is possible.There is no evidence to suggest the vitek® 2 gp id lot 242390310 is performing outside of specifications.Device not returned to manufacturer.

• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5858140
• MDR Text Key: 51738516
• Report Number: 1950204-2016-00090
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 07/11/2016

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: 08/21/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242390310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• 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