MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE TEST KIT; VITEK® 2 GP TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2017

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of a streptococcus pasteuri patient isolate in association with vitek® 2 gp id test kit (ref 21342, lot 2420352403).Per the customer, this patient was very ill when hospitalized.Endocarditis was suspected; therefore, a blood culture was done.On (b)(6) 2017, vitek® 2 identified the isolate from this patient's blood culture as streptococcus gallolyticus ssp pasteurianus.On (b)(6) 2017, the strain was sent out to be confirmed via sequencing method (16s rdna sequencing).The strain was confirmed as streptococcus pasteuri.On (b)(6) 2017, the patient expired due to gastrointestinal bleeding.The customer stated that there was no incorrect treatment.The patient was treated for endocarditis and received the usual treatment given for streptococci.The treatment was not dependent on the species.The customer stated that there was no delay in treatment or harm to the patient due to this discrepant result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) had notified biomérieux of a misidentification result when testing on two different lots of vitek® 2 gp id cards (2420352403 and 24203301133).Vitek 2 identified the strain as streptococcus gallolyticus ssp pasteruianus.The strain was confirmed as streptococcus pasteuri via 16s rdna sequencing method.An internal biomérieux investigation was performed.The customer did not submit the strain for further evaluation.This organism, streptococcus pasteuri, is not claimed for the vitek 2 gp id test kit.After research by the r&d strain collection department, it was determined that the species streptococcus pasteuri is not recognized by the taxonomy validation committee, so it is absent in lpsn, dsmz.In the ncbi taxonomy, the species is listed but with the comment "unpublished name", only the species s.Pasteurianus is cited.According to these elements, it is considered that there was no misidentification on the vitek 2 gp id card.The vitek 2 gp id cards performs as intended.

• Brand Name: VITEK® 2 GRAM POSITIVE TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6934991
• MDR Text Key: 90046192
• Report Number: 1950204-2017-00329
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420352403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1