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

Catalog Number	10400
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) reported a non conforming quality control strain in association with the api® nh (neisseria gonorrhoeae) test strip (lot 100678088).The customer stated that their qc organism (haemophilus influenzae atcc® 10211) was conforming on a previous lot of api test strips, but not on lot 1006780880.The customer then tested a new atcc® 10211 qc organism and lot 100678088 was not conforming.The customer switched to a different api nh lot and the issue was resolved.The atcc® 10211 qc strain is used to perform comprehensive quality control to demonstrate positive and negative reactivity with apnh.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A biomérieux internal investigation was conducted following a report of qc failure for haemophilus influenzae atcc® 10211¿ in association with the api nh test.1.Retained samples analysis.The conformity of the implicated lot 1006780880 and an internal reference lot 10066598040 used for the investigation were confirmed with the following atcc quality control strains tested for the release of this reference: atcc 31426 neisseria gonorrhoeae.Atcc 10211 haemophilus influenzae.Atcc 49917 haemophilus paraphrophilus.The results obtained for these strains with both lots are in agreement with the quality control specifications.2.Complaints trend analysis.No other complaint was registered on the lot 1006780880.No investigation was opened in the past for qc failed on this reference.3.Conclusion.The results obtained with the atcc quality control strains tested during the investigation conform with specifications.The issue observed by the customer was not reproduced on the retained sample tested.The investigation concluded that the api nh test kit is performing as intended.

• Brand Name: API® NH TEST STRIP
• Common Device Name: API® NH TEST STRIP
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8345218
• Report Number: 9615754-2019-00010
• Device Sequence Number: 19384104
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 05/22/2019
• Device Catalogue Number: 10400
• Device Lot Number: 1006780880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1