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

Model Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of discrepant results associated with vitek®2 gp test kit.The customer reported results that called organism latex typed as group g strep and tested on vitek® 2 as s.Agalactiae.The isolate was not repeated on vitek®2 and the customer did not provide further information regarding the testing performed.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer reported results for an organism latex typed as group g strep, and tested on vitek® 2 as s.Agalactiae.The isolate was not repeated on vitek®2 and the customer did not provide further information regarding the testing performed.An investigation was performed.The customer reported setting up the strain from tsab and incubating the plates for approximately 24 hours at 35°c in co2, which all follows the recommended procedure for testing the vitek 2 gp cards.Without the strain, lab reports, and raw data, it's not possible to further evaluate the cause of the misidentification.The gp lot 2420253203 met final qc release criteria and passed initial qc performance testing.The gp lot 2420253203 is associated with fsca 3445 card pouch integrity issue, and fsca 3666 gp id qc performance.

• Brand Name: VITEK®2 GP 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: 6885739
• MDR Text Key: 89263223
• Report Number: 1950204-2017-00315
• 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: 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
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2018
• Device Model Number: 21342
• Device Lot Number: 2420253203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2017
• 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