MAUDE Adverse Event Report: BIOMÉRIEUX SA API® 20 NE 25STRIPS+25MEDIA

Model Number 20050

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: api® 20 ne is a qualitative standardized system for the identification of non-fastidious, non-enteric gram-negative rods (for example, pseudomonas, acinetobacter, moraxella, vibrio, aeromonas).It uses miniaturized tests as well as a specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.Description: a customer in (b)(6) notified biomérieux of obtaining a misidentification of sphingomonas paucimobilis as burkholderia cepacia in association with the api® 20 ne 25strips+25media (ref 20050).No lot numbers have been provided by the customer.The customer reported obtaining an identification of burkholderia cepacia with the api 20 ne.The strain was then sent to an external laboratory where it was identified as sphingomonas paucimobilis by vitek® ms.Api 20 ne: burkholderia cepacia.Vitek ms: sphingomonas paucimobilis.Global customer service (gcs) reviewed troubleshooting information provided by the customer and identified that the customer is incubating the strips at 30 - 35 °c while the instructions for use require a temperature of 29 °c ± 2 °c (27 - 31 °c).Additional information provided by the customer indicated that the customer may be reading the api results after incubation durations that are longer than recommended in the instructions for use.According to the instructions, the results must be read at 24 hours and the strip should only be re-incubated if the following interpretations are observed on apiweb: low discrimination; unacceptable or doubtful profile; if the following note is indicated for the profile obtained: id not valid before 48-hr incubation.The reactions of the first three (3) tests of the strip (no3, trp, and glu) should only be read once at 24 hours (and the result after 48h not taken into account).There is no indication or report from the customer that this event led to any adverse event related to a patient's state of health.

Manufacturer Narrative

A customer in france notified biomérieux of obtaining a misidentification of sphingomonas paucimobilis as burkholderia cepacia in association with the api® 20 ne 25strips+25media (ref (b)(4)).The identification was not confirmed by the external laboratory with vitek ms method.Investigation the review of the production and quality control data for batch 1008808220, reference (b)(4), did not reveal any defect or anomaly that could explain the problem encountered.No other similar complaint has been registered on lot 1008808220, and biomérieux has not observed any trend of complaints for this type of defect on reference (b)(4) since 2018.The tests carried out according to biomérieux quality control protocol on the samples of lot 1008808220 comply with specifications; the performance of this batch is therefore not called into question.The problem of identification with burkholderia cepacia that the customer observed was not reproduced during the investigation on the strain submitted by the customer.The complaint investigation laboratory obtained an acceptable identification of moraxella spp and this result is consistent with the result obtained on vitek ms.Note: the strain received was not shpingomonas paucimobilis.The investigation did not reveal any issues regarding the performance of batch 1008808220.Complaint investigation laboratory was not able to reproduce the customer issue.

• Brand Name: API® 20 NE 25STRIPS+25MEDIA
• Type of Device: API® 20 NE 25STRIPS+25MEDIA
• 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 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12787562
• MDR Text Key: 288056059
• Report Number: 9615754-2021-00282
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 03573026047702
• UDI-Public: 03573026047702
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: 20050
• Device Catalogue Number: 20050
• Device Lot Number: 1008808220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1