MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® B·R·A·H·M·S PCT (TM)

Catalog Number 30450-01

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6), 2015 customer called to report an issue related to the negative range (false negative) when using product vidas b·r·a·h·m·s pct (tm) (pct), (b)(4), lot 1004045770.Upon retesting samples results were positive.Test results as follows: initial rfv = -2, result = <0.05 : repeat rfv = 6, result = 0.08.Second set of values : initial rfv = -2, result = <0.05 : repeat rfv = 323, result = 3.60.Customer reported no patient was harmed or treated incorrectly.

Manufacturer Narrative

Internal investigation was conducted.The analysis of the vidas® pct batch 1004045770 indicates no anomalies associated with the number of negative samples tested by the qc laboratory.For the investigation , eleven (11) negative samples were tested using batch 1004045770.Three (3) negative samples were obtained (relative fluorescence values at -1) with no change in interpretation.These negative rfv values near 0 do not indicate a lack of sensitivity.The discrepant results obtained by the customer are not due to negative rfv values.The performance of the batch vidas® pct 1004045770 is within specifications.

• Brand Name: VIDAS® B·R·A·H·M·S PCT (TM)
• Type of Device: VIDAS® B·R·A·H·M·S PCT (TM)
• 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: 5163755
• MDR Text Key: 29296719
• Report Number: 3002769706-2015-00124
• Device Sequence Number: 1
• Product Code: NTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2016
• Device Catalogue Number: 30450-01
• Device Lot Number: 1004045770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1