VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-04-21 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.

Event Text Entries

[43290134] (b)(4). The customers did not comply with biom? Rieux request for raw data or culture submittal. The customer for event #1 used a non-recommended media for patient isolate growth. Without the strain and/or raw data, it is not possible to determine a cause for the misidentification. The misidentification could be due to an atypical strain or a deviation in the recommended procedure for set up of the anc id card. Evaluation of the manufacturing batch records for the associated vitek 2 anc lots indicates the lots passed qc performance testing with no issues observed. The investigation concluded the vitek 2 anc test kit is performing in accordance with specifications. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10

[43290135] This report summarizes 2 malfunction events. A review of the events indicated that testing via the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit resulted in organism misidentifications. Bacteroides fragilis as bacteroides stercoris. Propionibacterium acnes as atopobium vaginae. Both events involved patients. There was no indication or report from the hospital or treating physician to biomerieux that the discrepant results led to any adverse event related to the patient's state of health. Culture submittals were requested for each event; however, the customers indicated the strains were no longer available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1950204-2016-00038
• MDR Report Key: 5595829
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2016-04-21
• Date of Report: 2016-04-30
• Date Added to Maude: 2016-04-21
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. RYAN LEMELLE
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3147318582
• Manufacturer G1: BIOMERIEUX, INC
• Manufacturer Street: 595 ANGLUM ROAD
• Manufacturer City: ST. LOUIS 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 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
• Generic Name: VITEK? 2 ANC CARD
• Product Code: JSP
• Date Received: 2016-04-21
• Catalog Number: 21347
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMERIEUX, INC
• Manufacturer Address: 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-04-21