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

Catalog Number	21346
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem 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.
Additional 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
• Common Device Name: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 6784344
• Report Number: 1950204-2017-00258
• Device Sequence Number: 16384859
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: CL. I 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2017
• Device Catalogue Number: 21346
• Device Lot Number: 245398920
• 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: 07/18/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1