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

Catalog Number	32700
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
Additional 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 or Problem 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
• Common Device Name: API® RAPID ID 32 E 25STRIPS
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10437425
• Report Number: 9615754-2020-00138
• Device Sequence Number: 2605485
• Product Code: JSS
• UDI-Device Identifier: 03573026066574
• UDI-Public: 03573026066574
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2020
• Device Catalogue Number: 32700
• Device Lot Number: 1007739570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1