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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification associated with vitek® gn test kit (reference 21341) involving an rcpa sample. The customer reported the organism was identified by the vitek® gn card as spingomonas paucimobilis twice and once as a slashline (brevundimonas vesicularis/diminuta) instead of brevundimonas vesicularis as expected. 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 from colombia reported discrepant values for the vidas® prolactin test kit when compared to the chemiluminescence method, for prolactin control samples from a patient that were tested on (b)(6) 2017. The customer did not provide a sample or test report for evaluation. An investigation was performed. A review of quality records confirmed the vidas® prolactin test kit (lot 1005172980) met specifications. The quality product laboratory has tested a calibration sample and six internal samples on a retained vidas® prolactin test kit (lot 1005172980). The results were: (b)(6). The results obtained for the calibration sample and six internal samples were within the specifications. The analysis of the control charts plus one additional sample of high concentration ([123. 5-199. 54] ng/ml 3is) showed that vidas® prolactin test kit (lot 1005172980) was within the trend of the other batches. The vidas® prolactin test kit (lot 1005172980) performed as intended. The customer did not provide a sample or information related to the other method used, thus further investigation is not possible.

Manufacturer Narrative

The previous supplement was incorrectly submitted and is not associated with this device and event.

Manufacturer Narrative

A customer reported a misidentification of a brevundimonas vesicularis rcpa survey strain as sphingomonas paucimobilis, when testing vitek® 2 gn card lots using vitek® 2 software version 7. 01. The customer did not submit the strain and raw data for evaluation. An investigation was performed. The customer submitted two lab reports for evaluation. Both lab reports showed an excellent identification of s. Paucimobilis. One report had two (2) atypical reactions (dcel+ and ggaa-) and the other had three (3) atypical reactions (dcel+, ggaa-, suct+) for an identification of b. Vesicularis according to the vitek® 2 gn knowledge base. A review of quality records confirmed the gn lots (241398040 and 241393910) met quality control performance testing and final release criteria. The investigation concluded that the strain exhibits atypical growth behavior. The vitek® 2 gn test kit performed as intended.

• Brand Name: VITEK 2 GN TEST KIT
• Type of Device: VITEK 2 GN 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: 6509086
• Report Number: 1950204-2017-00126
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: 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,Followup,Followup,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/26/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241393910
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial