MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG

Catalog Number 30204

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux that they experienced a false negative when using the vidas® cmv igg test.The customer retested the sample and produced the correct result.When specifically requested, the customer indicated there was no impact to patient or patient treatment.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux that they experienced a (b)(6) when using the vidas® cmv igg test.An internal biomérieux investigation was performed.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: no anomaly was observed during a review of biomérieux internal quality records.A visual inspection was performed on a retained kit of vidas® cmvg lot 1004170210 and no anomaly was observed.(b)(6) samples were tested on the retained kit of vidas® cmvg lot 1004170210.The results obtained for the five samples were within specification.The results on the control card for these five samples shows that vidas® cmvg lot 1004170210/160531-0 is in the trend on the other batches.According to an internal error table, if the customer forgets a sample or a solid phase receptacle (spr) during the analysis, it can cause a negative signal (rfv less than 0).Based on the internal record review, the likely cause of this event is the customer forgetting to put the sample on the strip or they forgot to add the spr.The investigation concluded the vidas®cmv igg lot 1004170210 performed as expected.

• 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: 5456352
• MDR Text Key: 38863164
• Report Number: 3002769706-2016-00037
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 30204
• Device Lot Number: 1004170210
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1