MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of streptococcus anginosus as streptococcus agalactiae in association with the vitek® 2 gram-positive (gp) identification (id) test kit.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the organism was subbed and testing included gp cards from the customer lot and a random lot, tested in duplicate.Api 20 strep was performed, as was vitek® ms.Additionally, 16s sequencing was performed.On all cards tested, an excellent id (99%) of s.Agalactiae was obtained.When api 20 strep was performed, a low discrimination of s.Constellatus (61%) and aerococcus urinae (20%) was obtained.Vitek® ms gave an identification of s.Constellatus, with a 99.9% confidence value.16s sequencing also gave an identification of s.Constellatus, with a 97% identity match.Therefore, the final identification is s.Constellatus.A comparison of expected reaction results for s.Constellatus against results obtained for s.Agalactiae revealed 2 atypical negative results (aglu, tyra) and 1 atypical positive result (lac) which led to the incorrect call.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• 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: 6764789
• MDR Text Key: 82921713
• Report Number: 1950204-2017-00249
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420307103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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