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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of a streptococcus pneumoniae control strain as kocuria kristinae in association with the vitek® 2 gp test kit.The streptococcus pneumoniae identification was confirmed with alternative methods.Testing with the gp card identified kocuria kristinae.The customer later reported that repeat identification and testing was performed.They stated that with increased optical density of the culture to 0.8 by (b)(6), the gp card gave the correct identification of streptococcus pneumoniae.The customer stated the incorrect result was not reported to a physician and no patient was impacted as the event pertained to a control strain.The customer stated they clean the vitek optics once per month and the last preventive maintenance was in (b)(6) 2015.The maximum density for the gp id cards is 0.63.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the customer reported setting up the strain from blood agar at 35c.No age of culture information provided and it appears the strain was not grown in co2 which is recommended for qc testing.The customer reported that the instrument had not had preventative maintenance since (b)(6) 2015 and that they irregularly perform verification of their densichek.The customer reported increasing their inoculum density to 0.8 mcfarland and got a correct identification.However the recommended range is 0.5 - 0.63 for testing in the gp card.Additionally it was noted that the customer's pre-analytical issues and been resolved and the situation is now resolved but no information was provided as to what the pre-analytical issues were.Three lab reports were submitted.The first lab report showed an 87% k.Kristinae identification with nine (9) atypical negative reactions (bgal, aglu, appa, aspa, leua, agal, nag, dmal, dmne) for an identification of s.Pneumoniae according to the gp knowledge base.Two (2) lab reports showed a 97% k.Kristinae identification with five (5) atypical negative reactions (appa, aspa, dmal, dmne, draf) for an identification of s.Pneumoniae according to the gp knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.Gp lot # 2420296403 met final qc release criteria.This lot passed initial qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• 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: 7161836
• MDR Text Key: 97413080
• Report Number: 1950204-2018-00008
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

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: 09/18/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420296403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2017
• 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