VITEK 2 AST-YS02 TEST KIT 22157

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-03-06 for VITEK 2 AST-YS02 TEST KIT 22157 manufactured by Biomerieux, Inc..

Event Text Entries

[4265644] On (b)(6) 2014, (b)(6), a customer in the united states reported a potential false susceptible fluconazole (flu) result for candida albicans using a vitek 2 ast-ys02 test kit. Testing at (b)(6) and an affiliate laboratory confirmed susceptible result for fluconazole; though the affiliate tested via trek (micro-titer method) and reported a higher susceptible dosage by two doubling dilutions. During additional testing ordered by the physician and performed by reference lab, the id/ast tests were again repeated and indicated the c. Albicans was resistant to fluconazole. (b)(6) laboratory investigation related to this discrepancy is being conducted. The patient isolate has been submitted to biomerieux for investigation. Specimen source was pelvic fluid from a patient admitted (b)(6) 2014 for pancreatitis. The patient also had vre (genus unknown) in a blood culture drawn on admission date ((b)(6) 2014). Patient treatment included the following antibiotics: micofungin, fluconazole, pipericillin, tazobactum, meropenem, linezolid, and daptomycin. On (b)(6) 2014, biomerieux was notified the patient had expired. Patient autopsy states the patient died as a result of: pancreatic cancer and colonitis due to sepsis (septic shock). Colonitis there is no evidence the vitek 2 or vitek 2 ast-ys02 test kit caused or contributed to the patient's death, the vitek 2 result also cannot be eliminated as a potential contributing factor in the patient death; therefore, we are reporting the event while biomerieux investigation occurs. At this time, there is no identified correlation between the patient's death and the vitek 2 products.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1950204-2014-00001
• MDR Report Key: 3716716
• Report Source: 05,06,07
• Date Received: 2014-03-06
• Date of Report: 2014-03-06
• Date of Event: 2014-02-11
• Date Mfgr Received: 2014-02-11
• Device Manufacturer Date: 2012-08-12
• Date Added to Maude: 2014-04-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: RYAN LEMELLE
• Manufacturer City: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3147318582
• Manufacturer G1: BIOMERIEUX, INC.
• Manufacturer Street: 595 ANGLUM RD.
• Manufacturer City: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal Code: 63042
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VITEK 2 AST-YS02 TEST KIT
• Generic Name: VITEK 2 AST-YS02 (YEAST) TEST KIT
• Product Code: NGZ
• Date Received: 2014-03-06
• Catalog Number: 22157
• Lot Number: 282261610
• Device Expiration Date: 2014-02-11
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMERIEUX, INC.
• Manufacturer Address: HAZELWOOD MO US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-03-06