MAUDE Adverse Event Report: BIOMERIEUX, SA API 20 E; API® 20 E

Catalog Number 20100

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

An internal complaint was initiated after completion of an investigation indicated that a customer had obtained a misidentification of klebsiella oxytoca as klebsiella pneumoniae in association with the api® 20 e 25 strips (ref (b)(4)).The customer initially reported a complaint against vitek® 2 gn id cards (ref.(b)(4)).Biomérieux initiated an investigation and confirmed that the vitek® 2 gn id card results were correct, and the customer¿s strain was klebsiella oxytoca.Biomérieux created a complaint against the api® 20 e (ref.(b)(4).The customer obtained the following results: vitek® 2 gn id card = klebsiella oxytoca; api® 20 e = klebsiella pneumoniae; isolate tested as indole negative.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation for the api® 20 e misidentification has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding a misidentification of klebsiella oxytoca as klebsiella pneumoniae in association with the api® 20 e 25 strips (ref (b)(4), lot 1007448620).Api® 20 e identified k.Pneumoniae (low discrimination) and vitek® 2 gn card identified k.Oxytoca (excellent id).An investigation was previously conducted on vitek® 2 which concluded to an identification as klebsiella oxytoca for the patient strain concerned.The lot number of api® 20 e used with the patient strain was communicated after the start of the investigation for the api® 20 e result.Therefore, the retained samples for the impacted lot number (1007448620) the customer reported were not tested.The following two api® 20 e lots (ref.(b)(4), lot number 1007693260, and ref.(b)(4), lot number 1007865190) were used for the investigation to analyze the strain provided by the customer.The strain gave the same identification results on both api® 20 e lots tested.The results obtained were low discrimination between klebsiella pneumoniae ssp pneumoniae 2, klebsiella pneumoniae ssp pneumoniae 1, and pantoea spp 2.The customer¿s identification of k.Pneumoniae ssp pneumoniae (low discrimination) was reproduced internally.Klebsiella oxytoca was not a proposed result.The patient¿s strain shows an atypical result on api® 20 e due to the indole test result that is negative instead of positive.The indole test is intended positive (99%) in the database of api® 20 e for klebsiella oxytoca species.While assessing the risk associated with this case, biomerieux assessed the severity to be negligible.A request to the customer is in progress to have the authorization to keep the customer strain in r&d for a future evolution of the api 20 e knowledge base.A batch record analysis was performed on the impacted lot number 1007448620.No observations or nonconformities were observed during the manufacturing process or the quality control testing.As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.No other complaints were registered for this issue and no other complaints were registered for the lot number 1007448620.Complaint trend analysis for this reference will continue to be monitored.See section h10.

• Brand Name: API 20 E
• Type of Device: API® 20 E
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10641165
• MDR Text Key: 210169553
• Report Number: 9615754-2020-00153
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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 Catalogue Number: 20100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1