MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

Catalog Number 30320

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a sampling issue (error 0522) for all vidas 3 instrument sections while performing a lyme igg assay.Other assays function as intended.Error 0522 is an alarm for which the goal is to prevent the potential reporting of an inaccurate result due to pumping issues.The error typically occurs when a smart pump is not functioning properly and needs to be replaced.In most cases, the assay would be performed in a different section, as was attempted by the customer for this occurrence.However, all sections failed with error 0522 for the lyme igg test.Error 0522 does not have an impact on the accuracy of reported results; however, the customer reported a four-day delay to report lyme igg assay results.There is no indication or report from the laboratory that the vidas 3 error 0522 condition associated with the lyme igg assay led to any adverse event related to any patient's state of health.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in france contacted biomérieux to report a sampling issue (error 0522) for all vidas 3 instrument sections while performing a lyme igg assay.An internal biomérieux investigation was performed.Results are as follows: a customer reported an error 0522 on vidas lyme igg batch 1004673730 / 170124-0.The analysis of the batch history records lot 1004673730 / 170124-0 shows no anomaly during the control process except the use of the "coating chamber".-testing included 15 sprs from each pouch on the in-house kit vidas lyme igg lot 1004673730 / 170124-0 and 12 sprs from each pouch on the return kit vidas®, so in total, 54 sprs were tested.The % of the error 0522 is: -1 error found for 30 strips and sprs tested so 3 % of errors with the retain kit lot 1004673730 / 170124-0.-1 error found for 24 strips and sprs tested so 4 % of errors with the return kit lot 1004673730 / 170124-0.One error 0522 was reproduced on the return kit and another on the retained kit; therefore, the recurrence was determined to be 3.7%.The update of the coating chamber to the 4th generation is needed to avoid such issue in the future.

• Brand Name: VIDAS® LYME IGG
• Type of Device: VIDAS® LYME IGG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 5736703
• MDR Text Key: 47794213
• Report Number: 3002769706-2016-00110
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2017
• Device Catalogue Number: 30320
• Device Lot Number: 1004673730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1