MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG

Catalog Number 30204

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported receiving a 522 error during liquid transfer while using the; vidas mv igg.

Manufacturer Narrative

A customer in (b)(6) reported receiving a blocking error "0522" during vidas® cmv igg (reference 30204/lot 1004289340) assay.An internal biomérieux investigation was conducted with the following results: - in the case of 0522 error, the following message is displayed on vidas® 3: "air detected when an aspiration is performed during the analytical protocol." as a consequence, the calibration or test is invalidated.The user is blocked until the test is repeated without error.-the error occurs while section «smart pump» (ref.6201417) is aspirating sample from the strip.-both assays (toxo igg and cmv igg) share the same protocol and are susceptible to react in the same manner (variability of pressure recorded) in case of variability in the spr production.Symptoms include: 0522 error/flag 0 occurring with some spr bags.-impact on biological result: users are blocked until they repeat the test and get results without error; however, according to customer logs and tests performed, the signal (rfv value) is not impacted by the 0522 error.The biological results are not impacted and the 0522 error reported by the vidas® 3 is considered a false alarm in this case.-the issue has been observed as an effect from batch manufacturing related to the spr itself.This creates a variability of pressure interpreted as error 0522 by the instrument.This phenomenon happens only with assays working with protocols where sample aspiration involves low volume and high speed.Assays using other protocols are not impacted.Pressure interpretation was designed to detect problems during aspiration (bubbles, leaks, pumps blocked), it is now disturbed by this phenomenon.This issue is being managed under a capa to identify root cause and provide corrective/preventative actions.Immediate action/workaround to avoid the false alarm is to rerun the calibration or test with a different spr from the second bag within the same kit or an spr from a new kit.

• Brand Name: VIDAS® CMV IGG
• Type of Device: VIDAS® CMV 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5383224
• MDR Text Key: 36535154
• Report Number: 3002769706-2016-00014
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K920661
• 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: 01/08/2016

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: 08/06/2016
• Device Catalogue Number: 30204
• Device Lot Number: 1004307640
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2015
• 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