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 in the united states reported to biomérieux discrepant results associated with vitek®2 gp test kit (reference 21342).The customer reported the gp card misidentified staphylococcus saprophyticus atcc baa 750 during a quality control (qc) test.There is no patient associated with these results because this is a quality control sample.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states reported to biomérieux a misidentified staphylococcus saprophyticus (atcc baa 750) in association with the vitek®2 gp test kit (reference 21342).The customer submitted the strain for evaluation.An investigation was performed.The customer strain and the internal quality control strain were subcultured to tsab plates.Each strain was tested on gp cards from the two (2) customer's lots and one (1) random lot, in duplicate.All twelve (12) gp cards tested gave the expected negative reactions for amy (d-amygdalin), cdex (cyclodextrin), pul (pullulan), draf (d-raffinose), and sal (salicin) with no misidentifications.The vitek®2 gp cards performed as expected for both strains.An increase in atypical reactions can indicate an issue with the set up procedure, an atypical strain, mixed culture , contamination or decreased viability.

• 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: 7003395
• MDR Text Key: 92174586
• Report Number: 1950204-2017-00366
• 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: 01/08/2018

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: 02/26/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420457403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1