MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GN TEST KIT; VITEK® 2 GN TEST CARD

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a misidentification of shigella sonnei for a stool culture in association with the vitek 2 gn test kit.Initial and repeat testing of the isolate with the gn test card resulted in an identification as shigella sonnei.The shigella sonnei result was reported to the physician with confirmation forthcoming from the state laboratory.The state laboratory then identified the isolate as negative for shigella species.The customer stated that the reported results did not impact patient treatment or state of health.The customer reported they no longer have the isolate.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux internal investigation was conducted for a misidentification; however, the customer did not comply with a biomérieux request for raw data and patient isolate submittal.Information about the vitek® 2 gn card set up was not provided.One isolate was from a stool culture and the other was from sputum.It was noted that one strain was set up from macconkey agar and unknown for the other isolate.Two lab reports were submitted with both showing excellent identification of shigella sonnei.However, a reference identification was not provided, therefore no analysis of atypical reactions could be made.When a result of shigella sonnei is reported, the following message is printed on the vitek® 2 lab report: "confirm by serological tests.A review of quality control records confirmed the lot met the criteria for release and performance testing.No further investigation is possible without the raw data or isolate.

Manufacturer Narrative

A second supplementary medwatch report is being submitted because fields b.4 and g.4 were erroneously omitted on the first supplement.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6212448
• MDR Text Key: 63628004
• Report Number: 1950204-2016-00215
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1, 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241371840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• 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: N
• Patient Sequence Number: 1