MAUDE Adverse Event Report: BIOMÉRIEUX, SA API RAPID ID 32 E 25STRIPS; API® RAPID ID 32 E 25STRIPS

Catalog Number 32700

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

In response to the customer complaint biomérieux conducted an internal investigation.A review of the api® data determined cronobacter spp.Cannot be identified with the api® rapid id 32 e 25strips.Internal quality control testing was performed in triplicate using impacted lot 1007739570 and reference lot 1007999700.The organisms tested were klebsiella oxytoca cq104 atcc¿ 43863, proteus mirabilis cq106 atcc¿ 35659, and morganella morganii cq116 atcc¿ 25829.All results from both lots were within specification.The impacted strain was requested but not submitted.

Event Description

An industry customer in (b)(6)notified biomériux of a misidentification of cronobacter strains as enterobacter cloacae species in association with the api® rapid id 32 e 25strips (ref.(b)(4), lot.1007739570) when testing colonies originally sourced from milk powder.The sample was tested using gene-up which obtained a cro positive result.The organism was then subcultured onto esia agar blue-green colonies were observed indicating cronobacter.Then colonies were subcultured on a nutritive agar and the confirmation of the identification performed with the impacted lot of rapid id 32 e strips that gave enterobacter cloacae species instead of cronobacter as expected.As there is no patient associated with this industry strain, there is no adverse event related to any patient's state of health.

• Brand Name: API RAPID ID 32 E 25STRIPS
• Type of Device: API® RAPID ID 32 E 25STRIPS
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3 route de port michaud; la balme
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042 ; 3145068201
• MDR Report Key: 10437425
• MDR Text Key: 206170614
• Report Number: 9615754-2020-00138
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 03573026066574
• UDI-Public: 03573026066574
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

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: 08/18/2020
• Device Catalogue Number: 32700
• Device Lot Number: 1007739570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/21/2020
• Date Device Manufactured: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1