FDA Adverse Event Injury Summary report: N

VITEK® 2 AST-GP75

MDR report key: 6553564 · Received May 9, 2017

Report

Report Number: 1950204-2017-00151
Event Type: Injury
Date Received: May 9, 2017
Report Date: June 27, 2017
Manufacturer: BIOMERIEUX, INC
Product Code: LON
UDI-DI: 03573026437183
PMA / PMN Number: K072668
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE STRAIN WAS NOT SUBMITTED TO BIOMÉRIEUX, THEREFORE, THE ISSUE CANNOT BE CONFIRMED. INTERNAL DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCY OR ANOMALY WAS OBSERVED DURING THIS REVIEW.

Description of Event or Problem · 1

A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A FALSE RESISTANT VANCOMYCIN RESULT FOR A STAPHYLOCOCCUS AUREUS ORGANISM (VRSA) IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE CUSTOMER STATED SHE WAS REQUIRED TO SUBMIT AN INCIDENT REPORT TO THE STATE LAB REGARDING THE VRSA RESULT. IN ADDITION, THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY; THAT FACILITY NOTIFIED THE CUSTOMER THAT THEIR TESTING DID NOT PRODUCE A VRSA RESULT. THE VANCOMYCIN RESULT WAS SUSCEPTIBLE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE IMPACT RELATED TO THE PATIENT'S STATE OF HEALTH. HOWEVER, THE DISCREPANT VANCOMYCIN RESULT INITIATED A PATIENT TRANSFER TO A DIFFERENT FACILITY. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
336543	VITEK® 2 AST-GP75	VITEK® 2 AST-GP75	LON	BIOMERIEUX, INC		2750173203	03573026437183

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other