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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG

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BIOMERIEUX SA VIDAS® CMV IGG Back to Search Results
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.
 
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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 Key5383224
MDR Text Key36535154
Report Number3002769706-2016-00014
Device Sequence Number1
Product Code LFZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K920661
Number of Events Reported1
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 Date08/06/2016
Device Catalogue Number30204
Device Lot Number1004307640
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2016
Initial Date FDA Received01/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/20/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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