MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT; VITEK® 2 GN ID TEST KIT

Catalog Number 21341

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)64) contacted biomérieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek® 2 gram-negative (gn) identification (id) test kit.Repeat test obtained proteus hauseri.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the external control strain.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek® 2 gram-negative (gn) identification (id) test kit.Repeat test obtained proteus hauseri.An internal biomérieux investigation was performed.The submitted isolate was subcultured and vitek® 2 gn card testing included individual organism suspensions on each of the two (2) customer implicated lots (241394340 and 241396640) as well as a random lot, in duplicate.Also performed was api® 20 e test strip testing.All six (6) vitek® 2 gn cards tested resulted in the same low discrimination identification of proteus penneri/proteus hauseri.The api® 20 test strip resulted in an excellent identification (b)(4) of proteus vulgaris group.Note, the isolate demonstrated swarming on tsab agar, compatible with an identification of proteus vulgaris.A review of the customer's proteus penneri/proteus hauseri data against expected reactions for proteus vulgaris demonstrated five (5) atypical negative reactions (off, bglu, proa, 0129r and ggaa), according to the gn knowledge base, contributing to the misidentification.Review of the internal proteus penneri/proteus hauseri data demonstrated three (3) of the same atypical negative reactions (bglu, proa and ggaa).An increased number of atypical negative results can indicate a strain with decreased viability or an atypical strain.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN 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: 6368612
• MDR Text Key: 68974755
• Report Number: 1950204-2017-00078
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241394340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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