MAUDE Adverse Event Report: BIOMERIEUX SA API® 20 A STRIPS

Catalog Number 20300

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015, a customer contacted biomerieux to report a mis-identification of bifidobacterium species when using api 20 a strips.The customer conducted additional testing with the vitek ms and identified the sample as parabacteroides distasonya.The results from the vitek ms were communicated to the treating physician; there was no delay in results or patient treatment.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The strain submitted by the customer was tested via the following methods: api® 20 a strips (two strips each from customer lot and a random lot).Vitek® 2 anc id test kit.Vitek® ms.All test methods returned the expected result of parabacteroides distasonis.The discrepant result obtained by the customer could not be reproduced.The api 20 a strip is performing in accordance with specifications.

• Brand Name: API® 20 A STRIPS
• Type of Device: API® 20 A STRIPS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5180884
• MDR Text Key: 30041316
• Report Number: 3002769706-2015-00130
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL I, EXEMPT
• 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: 10/08/2015

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: 04/24/2016
• Device Catalogue Number: 20300
• Device Lot Number: 1003848900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1