MAUDE Adverse Event Report: BIOMÉRIEUX, SA API NH 10STRIPS+10MEDIA

Model Number 10400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: api® nh is a qualitative standardized system for the identification of neisseria, haemophilus (and related genera) and moraxella catarrhalis (branhamella catarrhalis).It uses miniaturized tests as well as a specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.The complete list of those organisms that it is possible to identify with this system is given in the technical brochure - information for identification software.Api® nh also enables the biotyping of haemophilus influenzae and haemophilus parainfluenzae, as well as the detection of a penicillinase.Description of the issue: a customer in (b)(6) notified biomérieux of obtaining a misidentification of haemophilus influenzae atcc® 49247¿ as haemophilus parainfluanzae during internal quality control testing with api® nh, lot 1008318370.The customer reported that the repeat test with api® nh, lot 1008518850 with the same strain gave the expected identification.As it concerns a quality control, no patient impact has been reported.To be noted that the strain used by the customer is not included in the routine quality control set for api nh.It is indicated in the package insert that : "quality control strains are chosen for their reaction performance rather than for their identification performance.In general, quality control strains are identified with a single taxon, low discrimination or mixed taxa.It may happen that an atcc® strain is misidentified when all expected quality control reactions are correct." a biomérieux internal investigation will be initiated.

Manufacturer Narrative

The customer had reported obtaining a misidentification using the product api® nh strips (ref.10400; lot# 1008318370).Identification of haemophilus parainfluenzae (profile 7724 - id%= 98,7 and t= 0,77) was obtained for the atcc® strain 49247¿ known as haemophilus influenzae.The customer retested the same strain on another lot of api nh (# 1008518850) and obtained the expected identification of h.Influenzae.Identification was confirmed by mass-spectrometry technology as h.Influenzae.No patient impact was reported due to this misidentification.The customer returned three strips of api nh lot number 1008318370 for the biomérieux investigation.Retained samples analysis: retained samples for api nh strips (ref.10400; lot# 1008318370) were tested in parallel with the same api nh strips (lot#1008518850) that the customer used as reference.Biomérieux used three atcc quality control (qc) strains mentioned in the api nh package insert : neisseria gonorrhoeae atcc® 31426¿, haemophilus influenzae atcc® 10211¿, haemophilus paraphrophilus atcc® 49917¿.Two additional strains were tested during the investigation : haemophilus influenzae atcc® 49247¿, haemophilus parainfluenzae cq 87.10.023 (additional qc strain for batch release).A total of ten (10) strips were tested (one identification strip per lot per strain).All profiles obtained conformed to the expected results for the five (5) strains tested and on both lots of api nh strips.On both lots, the atcc® 49247¿ strain gave a very good identification to haemophilus influenzae with id%= 99.9 and t= 0.74 or 0.72.The quality of the reported lot remains within specifications.Returned samples analysis: biomérieux received three strips of api nh lot number 1008318370 from the customer for investigation.The strips returned were tested with the three strains below: h.Influenzae atcc® 10211¿, h.Influenzae atcc® 49247¿, h.Parainfluenzae cq 87.10.023.The results obtained for h.Influenzae atcc® 10211¿ and h.Parainfluenzae cq 87.10.023 conformed with expected results.The identification result obtained for the strain h.Influenzae atcc® 49247¿ gave a very good identification of h.Influenzae with id%= 99.9 and t= 0.74.The results obtained were equivalent between the retained kits of the impacted lot and the strips returned.The investigator was unable to duplicate the customer's misidentification with the strain atcc® 49247¿.Complaint analysis on the 05th july 2021, the complaints database was reviewed looking for similar reports.No other complaint was registered on this lot number of api nh.Conclusion the quality control strains tested during the investigation on the retained samples of the product api nh (ref.10400; lot# 1008318370) complied with specifications.In addition, no other complaint have been submitted on this lot number for similar misidentification.Biomérieux did not reproduce the misidentification obtained with the h.Influenzae atcc® 49247¿.Expected identification and equivalent results were obtained between the retained samples and the returned strips of the impacted lot number of api nh.The investigation results and the trending analysis performed on the impacted lot number did not identify any product performance issue, neither corrective nor preventive actions will be implemented.

• Brand Name: API NH 10STRIPS+10MEDIA
• Type of Device: API NH 10STRIPS+10MEDIA
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 12083713
• MDR Text Key: 281603770
• Report Number: 9615754-2021-00177
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035600
• UDI-Public: 03573026035600
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Model Number: 10400
• Device Catalogue Number: 10400
• Device Lot Number: 1008318370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1