MAUDE Adverse Event Report: BIOMERIEUX, SA API® NH

Catalog Number 10400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Meningitis (2389)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a misid issue while using; api® h.A (b)(6) patient with a fever was being tested in the emergency room and there was an identification of a strain of neisseria meningitis.The strain was retested and the results returned the same; neisseria sp.There was a delay of ten days and the patient could not be treated in the emergency room.

Manufacturer Narrative

A customer in (b)(6) reported an identification issue while using api nh batch 104345520 involving a three (3) month old patient with a fever and no other symptoms.In the emergency room, the strain was identified as (b)(6).The sample was subsequently sent to (b)(4) institute where it was confirmed as (b)(6).Using the same strip batch; however, the test was repeated using another strip batch (1003265461) and the result was neisseria meningitidis.(b)(4) institute confirmed the neisseria meningitidis identification by pcr.Results of the internal investigation are as follows: testing : api nh batch number 1004345520, using all components of the kit.The second batch used by (b)(4) institute could not be tested due to the expiration of the batch; however, another batch was tested (1004158211).(b)(6).The patient strain was not tested since the customer was unable to submit the strain for the investigation.Results: all results within specifications for batch 1004345520.All results within specifications for batch 1004158211.Complaint history review- no other complaints for the batch.Conclusion : the customer's observation was not reproduced with batch numbers 1004345520 or 1004158211.Product tested is performing within specifications.As the patient's strain could not be tested, it was not possible to explain why the strip did not succeed in identifying the neisseria specie as indicated by the customer.

• Brand Name: API® NH
• Type of Device: API® NH
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5392703
• MDR Text Key: 37342308
• Report Number: 3002769706-2016-00028
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: AG
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2016
• Device Catalogue Number: 10400
• Device Lot Number: 1004345520
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 3 MO