MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS D DIMER EXCLUSION

Catalog Number 30455

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015 a (b)(6) customer reported a false elevated result obtained with vidas® dimer exclusion ii (tm), ref (b)(4), lot 1004051950 (expiration date: 18-may-2016).The patient ((b)(6) woman) suffered from a chest pain.No additional patient information was provided.The vidas® dimer exclusion ii (tm) test was performed on (b)(6) 2015 and the result was positive (645.66 ng/ml).The instructions for use (ifu) of the test d dimer exclusion ii ref.(b)(4), state that : "in a study carried out using 215 citrated plasma samples from blood donors, 90% of values were below 500 ng/ml (feu).The result were given to the physician who decided to hospitalize the patient due to the vidas® dimer exclusion ii result.An additional test d-dimer (it is unknown which method was used) gave a negative result (350 ng/ml for a threshold at 400 ng/ml).

Manufacturer Narrative

Biomérieux internal investigation was conducted.Review of the corresponding batch qc records indicated no anomalies identified for vidas® ddex ii batch 1004051950.The product performed in accordance with specifications.Testing of the plasma specimen submitted by the customer produced the expected results as compared to the stago star test.The discrepant result obtained by the customer could not be reproduced.

• Brand Name: VIDAS D DIMER EXCLUSION
• Type of Device: VIDAS D DIMER EXCLUSION
• 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: 5146878
• MDR Text Key: 28142239
• Report Number: 3002769706-2015-00115
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K094882
• 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: Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2016
• Device Catalogue Number: 30455
• Device Lot Number: 1004051950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention