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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed.The cap d-10 survey specimen was not graded due to the lack of participant and referee consensus.Referees demonstrated 49.2 % and participants 56.2 % consensus for correct identification of all organisms.The bmx internal cap d-10 strain was rehydrated and subcultured under anaerobic conditions.Testing included individual organism suspensions on anc cards from four (4) different lots, in duplicate.Testing was also performed with vitek® ms.The eight (8) anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result.The vitek® ms resulted in the expected identification of propionibacterium granulosum (99.5%).A review of customer's results against expected reactions for p.Granulosum, demonstrated several atypical negative reactions (ellm, pyra, arg, pvate, amani, drib).Many survey participants additionally entered atypical positive morphology (cocci) according to the anc knowledge base all contributing to the misidentification.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The investigation concluded the submitted isolate has an atypical biochemical profile.

Event Description

A customer from the united states reported to biomérieux a misidentification of an ungraded cap survey sample (simulated joint tissue) in association with the vitek® 2 anc test kit.The sample was identified as peptostreptococcus anaerobius with the vitek® 2 anc card and was reported.The customer was informed the correct identification was propionibacterium granulosum.The customer then repeated the anc test and the result was low discrimination organism.There was no patient involvement as this event was for a survey sample.The customer submitted the lab reports for evaluation.

• 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: 6959339
• MDR Text Key: 90592939
• Report Number: 1950204-2017-00342
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21347
• Other Device ID Number: 03573026144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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