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

Catalog Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of an aerococcus sanguinis gram positive cocci urine sample, in association with the vitek® 2 anc test kit.The sample was tested twice with the anc card and the results were unidentified organism and anaerococcus prevotii.The isolate was cultured on cos (columbia sheep blood) media.The customer sent the sample to an external laboratory and the result was aerococcus sanguinis by maldi-toff.The customer stated the incorrect result of anaerococcus prevotii was reported to the physician but patient results and treatment was not affected.There was a 48 hour/ 72 hour delay for reporting results.The lab reports and isolate were requested from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported to biomérieux a misidentification of a gram positive cocci urine sample, in association with the vitek® 2 anc test kit.The customer submitted the isolate and card lot for evaluation.An investigation was performed.The reference method (sequencing full 16s) was used to determine the intended result, which gave an excellent identification to the species a.Sanguinicola (99.92%).The vitek® ms v3.2 confirmed the a.Sanguinicola identification.The vitek® ms v3.0 gave an unidentified result as the species a.Sanguinicola doesn't belong to the v3.0 knowledge base.Vitek® gp cards from the customer lot (cl 242394510) and random lot (rl: 2420157103) gave an excellent identification to the species a.Viridans (97%) on both lots tested.Vitek® anc cards from the customer lot (cl: 2440062203) and random lot (rl: 244379420) gave an unidentified organism on both lots tested.The species a.Sanguinicola is not included in the vitek® 2 v7.01 gp and anc cards knowledge base.There is a limitation for species not claimed in the knowledge base : testing of unclaimed species may result in an unidentified result or a misidentification.The investigation concluded the gp and anc cards performed as intended and no further action is required.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: 6453911
• MDR Text Key: 71596136
• Report Number: 1950204-2017-00103
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

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: 01/27/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440062203
• Other Device ID Number: 03573026144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: 06/06/2017
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1