MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP TEST KIT; VITEK® 2 GP TEST CARD

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux a misidentification of staphylococcus aureus as staphylococcus warneri for a blood culture sample in association with the vitek 2 gp test kit.The isolate was tested with vitek ms which repeatedly produced a result of staphylococcus aureus.The customer reported the isolate colony was catalase positive and coagulase negative, so it was tested with the vitek 2 gp which identified staphylococcus warneri (93%).It was reported that incubation for the susceptibility card was terminated, with a majority of the antibiotics listed as susceptible.Staphylococcus warneri was the reported result based on colony morphology (unusual appearance and beta-haemolytic), the catalase test (positive) and the latex agglutination (negative).All these coupled with the identification given by vitek 2 gp, it was determined to be staph warneri.The customer reported the patient was discharged after the result was amended to staph warneri and there has been no impact or issue with the patient since the discharge.Further testing of the isolate with the bruker system gave an identification of staphylococcus aureus.Repeat testing with vitek 2 gp identified aerococcus viridans (93%), and 16s rrna sequencing gave a staphylococcus aureus result.Test reports and the isolate were requested from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux a misidentification of staphylococcus aureus as staphylococcus warneri for a blood culture sample in association with the vitek® 2 gp test kit.The customer submitted the isolate for evaluation.An investigation was performed.The submitted isolate was subcultured, and testing included vitek® 2 gp cards from the customer's lot and a random lot, in duplicate.The api® staph test kit and the vitek® ms were also used.The subculture confirmed the customer's reported suboptimal growth of this atypical s.Aureus, consistent with a small colony variant staph strain.Two gp cards resulted in low discrimination identifications aerococcus viridans/staph saprophyticus; one gp card gave a low discrimination identification of aerococcus viridans/staph saprophyticus/staph xylosus, and the other gp card gave a very good identification of staph saprophyticus confirming the vitek® 2 misidentification of this strain.The api® staph test resulted in a good identification to genus (6702052) s.Epidermidis 48.3% / s.Hominis 44.0%.Vitek® ms identified the strain as s.Aureus.Review of the s.Warneri data against the expected reactions for s.Aureus demonstrated one atypical positive (ure) and three atypical negative reactions (aglu, phos, and pyra) contributing to the misidentification.Review of the aerococcus viridans data against expected reactions for s.Aureus demonstrated one atypical positive (ure) and three atypical negative reactions (adh1, aglu, and phos) contributing to the misidentification.An increased number of atypical negative results can indicate a strain with decreased viability or an atypical strain.The investigation concluded the submitted isolate has an atypical biochemical profile.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6349874
• MDR Text Key: 68224966
• Report Number: 1950204-2017-00063
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2017
• Device Catalogue Number: 21342
• Device Lot Number: 2420026403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1