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

Catalog Number 21341

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

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

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomɒieux to report a misidentification of paracoccus sanguinis as brucella melitensis in association with the vitek 2 gn id test kit. Testing via maldi-tof did not provide an organism identification. The sample was a blood culture after colonoscopy from a patient with recurring fever after a long-term stay on (b)(6). Upon obtaining the result of brucella melitensis: the laboratory safely stored the strain. The laboratory staff (three persons) were treated same day with amphotericin sulbactam (ab) due to potential exposure to a select agent. The strain was sent to a reference laboratory for confirmatory testing; paracoccus sanguinis was identified by the reference laboratory (testing method unknown). No dna of brucella was found. The customer indicated the organism misidentification did not lead to any adverse event related to the patient's state of health; details regarding patient treatment were not provided by the customer. Additionally, the three laboratory personnel are showing no signs of adverse impact and remain in good health. As the strain is potentially a select agent, submission to biomerieux was not appropriate. Biomerieux internal investigation was conducted. The investigation concluded: paracoccus sanguinis is not a claimed species for the vitek 2 gn id card. When an isolate is tested in the gn id card, the gram negative knowledge base will attempt to match the reactions to known bio patterns stored in the knowledge base. If the reaction pattern of an unclaimed species is tested and match those in the knowledge base with a high degree of confidence, a misidentification can occur. The vitek 2 product information contains the following warning in the limitations section: "testing of unclaimed species may result in an unidentified result or a misidentification. " when an identification of brucella melitensis is reported by the gn id card, the system software prints the following message on the laboratory report: "important! presumptive identification. " a presumptive identification should always be confirmed with another method before reporting results. Review of complaint history for the last thirteen (13) month timeframe revealed one other complaint of a misidentification as brucella, and indicates the report was also due to testing of an unclaimed species (roseomonas rosea). The vitek 2 gn id test kit and associated knowledge base are performing as intended. Product labeling and software provide information to ensure additional attention for organism identifications of brucella melitensis.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN 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: 5864597
• MDR Text Key: 51732296
• Report Number: 1950204-2016-00091
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 21341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/10/2016 Patient Sequence Number: 1