MAUDE Adverse Event Report: BIOMERIEUX SA API® 20E TEST STRIP

Catalog Number	20100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) contacted biomérieux to report the occurrence of a misidentification of raoultella planticola (external qc strain) as klebsiella pneumonia in association with the api® 20e test.No alternate test method or confirmatory testing was performed by the customer.The external qc testing was performed one year ago; the strain is no longer available for retest.Prior to 2001, the name of raoultella planticola was klebsiella planticola.The biochemical characteristics between raoultella planticola and klebsiella pneumonia are similar.It is important to note that raoultella planticola is not in the api® 20e database; therefore, it is not possible to identify raoultella planticola theapi® 20e test strip.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.There was no patient directly associated with the qc strain.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
During an external quality control (qc )(ring trial, rfb), the customer tested api® 20 e strips and obtained a "bad identification" to "klebsiella pneumoniae" at 97.3%.The intended identification was "raoultella planticola." an internal biomérieux investigation was initiated; however, the external qc took place one (1) year ago so the strain is no longer available.In addition, there was no return of the api 20 e strips and the lot number of the batch was unknown.In the absence of information, including customer troubleshooting , investigation could not be done internally.Consequently, it was not possible to determine the probable cause of the issue and to implement action.Note: prior to 2001, the name of raoultella planticola was "klebsiella planticola".The article, "international journal of systematic and evolutionary microbiology" (2001), 51, 925-932 by m.Drancourt, title "phylogenetic analyses of klebsiella species delineate klebsiella and raoultella gen.Nov, with description of raoultella ornithinolytica comb.Nov., raoultella terrigena comb.Nov.And raoultella planticola comb.Nov." mentions: " cluster ii contained klebsiella ornithinolytica, klebsiella planticola, klebsiella trevisanii and klebsiella terrigena, organisms characterized by growth at 10°c and utilization of l-sorbose as carbon source.[.] the name raoultella as a genus name for species of cluster ii and emended definitions of klebsiella species are proposed." in addition, the "raoultella planticola" is not in the database of the api 20 e strips, so it is not identifiable with these strips.Api 20 e strips gave identification to "klebsiella pneumoniae" because it is a closer strain to "klebsiella planticola" (="raoultella planticola").

• Brand Name: API® 20E TEST STRIP
• Common Device Name: API® 20E TEST STRIP
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383; FR
• MDR Report Key: 7344955
• Report Number: 3002769706-2018-00042
• Device Sequence Number: 18847496
• Product Code: JSS
• UDI-Device Identifier: 03573026047818
• UDI-Public: 03573026047818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: CL. I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 20100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1