MAUDE Adverse Event Report: BIOMERIEUX, SA API ® 20 NE

Catalog Number	20050
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported to biomérieux misidentification associated with api® 20 ne.The customer reported the expected identification to be burkholderia cepacia but the actual result was pseudomonas aeruginosa.Samples were sent to another site for repeat testing using maldi and the result was p.Aeruginosa.The incorrect result was reported to the physician.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in canada reported a misidentification of burkholderia cepacia as pseudomonas aeruginosa in association with api® 20 ne lot 1005788170.An investigation was performed.Regarding the knowledge base api 20 ne v8.0 (technical brochure rev 161150-745-fr -a -2016-03-161150 -745, current version), there are six (6) tests between b.Cepacia and p.Aeruginosa strains : no3, adh, pnpg, araa, mnea and paca.The customer's strain was not available for testing.A retention kit from the customer lot 1005788170 and reference lot 1005830760, were tested using the four (4) strains mentioned in the current package insert (rev 07615k-xl-2009/11) - aeromonas hydrophila atcc 35654 - alcaligenes faecalis atcc 35655 - sphingobacterium multivorum atcc 35656 - pseudomonas aeruginosa atcc 27853 compliant results were obtained with all four (4) strains tested with the retention lot 1005788170.Compliant results were obtained with all four (4) strains tested with the reference lot 1005830760.The strains mentioned in the instruction for use were tested internally and produced no discrepant results for lot 1005788170.The api 20 ne test strips performed as expected.

• Brand Name: API ® 20 NE
• Common Device Name: API ® 20 NE
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7274425
• Report Number: 3002769706-2018-00016
• Device Sequence Number: 122909
• Product Code: JSS
• UDI-Device Identifier: 03573026047702
• UDI-Public: 03573026047702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CL 1 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): 05/07/2018

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 Expiration Date: 06/20/2018
• Device Catalogue Number: 20050
• Device Lot Number: 1005788170
• 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: 01/18/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1