MAUDE Adverse Event Report: BIOMERIEUX SA API® NH TEST STRIP

Model Number	10400
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) notified biomérieux of discrepant results associated with api nh (reference 10400).The customer reported the expected identification as neisseria sicca and the actual result was neisseria gonorrhoea 98% (good id).Repeat testing confirmed the misidentification.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following a report of discrepant results associated with api® nh (reference 10400).The customer stated the expected identification as neisseria sicca; however, the result obtained was neisseria gonorrhea 98% (good id).Repeat testing confirmed the misidentification.An internal biomérieux investigation was performed.Due to the expiration (28sep2017) of the incriminated batch (lot 1005423530), testing was not possible; however, the strain, atcc 9913 neisseria sicca, was tested via api nh strips.The results were compliant with a "very good identification" to neisseria spp at 99.9%.Analysis of the batch record, including bacteriological tests, indicates all criteria for release were compliant.According to the package insert rev 07487p-xl-2016/12 (current version), the knowledge base of the strip is limited to neisseria spp.Complementary tests are necessary to identify the genus to neisseria sicca.Conclusion: due to the expiration of the impacted api nh strips, testing couldn't be performed in the biomérieux qc laboratory.However, a previous study on strain atcc 9913 neisseria sicca at biomérieux showed this strain is correctly identified with the api nh strips.

• Brand Name: API® NH TEST STRIP
• Common Device Name: API® NH TEST STRIP
• Manufacturer (Section D): BIOMERIEUX SA; te, 3 route de port michaud; 38390 la balme-les-grottes; FR
• MDR Report Key: 6917592
• Report Number: 3002769706-2017-00289
• Device Sequence Number: 1239202
• Product Code: JTO
• UDI-Device Identifier: 03573026035600
• UDI-Public: 03573026035600
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: C1 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): 02/19/2018

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: 09/28/2017
• Device Model Number: 10400
• Device Lot Number: 1005423530
• 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: 09/08/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1