MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT; VITEK® 2 NH ID TEST KIT

Catalog Number 21346

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of neisseria gonorrhoeae as neisseria cinerea in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.Due to suspicion of neisseria gonorrhoeae based on gram stain and clinical presentation, the customer performed pcr testing and obtained the neisseria gonorrhoeae result.The customer stated the discrepant vitek® 2 nh id result was not reported to the treating physician; the pcr result was used by the physician for treatment decisions.There was no adverse impact on the patient's state of health due to the discrepant result.Culture submittal was requested by biomérieux for internal investigation.However, the customer stated the strain is no longer viable for testing.Biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the customer reported testing the isolate from pvx media which had been incubated at 37c in co2.The percentage of co2 used was not reported.The customer remarked the card was set up right after the strain was removed from the co2 incubator.Three (3) lab reports were submitted.The first lab report showed an excellent identification of n.Cinerea with 3 atypical negative reactions (tyra, appa, dglu) and one atypical positive reaction (ellm) for an identification of n.Gonorrhoeae according to the nh knowledge base.The other 2 lab reports showed low discrimination identifications between n.Gonorrhoeae and n.Elongata.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.Nh lot# 245398920 met final qc release criteria.The lot passed initial qc performance testing.

• Brand Name: VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6784344
• MDR Text Key: 83307944
• Report Number: 1950204-2017-00258
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL. I 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: 10/23/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2017
• Device Catalogue Number: 21346
• Device Lot Number: 245398920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1