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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a misidentification of an enterococcus casseliflavus (atcc 700327) quality control sample, as enterococcus gallinarum, in association with the vitek® 2 gp test kit.The customer stated there was an issue with the bgar (beta galactropyranosidase) result.There was no patient involvement as the event pertained to a quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the customer's strain was not submitted for investigation.The internal biomérieux quality control strain was subcultured to remel tsab media and testing included individual organism suspensions with gp cards from the customer's lot and from a random lot, in duplicate.The four (4) gp cards all gave the expected positive bgar reactions.No qc deviations or misidentifications were observed.Without the customer's qc strain or data submittal it is not possible to further determine the cause of the reported misidentification.Vitek®2 gp cards performed as expected for this strain.Gp lot # 2420393403 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• 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: 7228041
• MDR Text Key: 98639189
• Report Number: 1950204-2018-00051
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420393403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2017
• 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