MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® D DIMER EXCLUSION II (TM)

Catalog Number 30455

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015 the customer, in (b)(6) (private laboratory) reported they had observed falsely elevated test results when using product vidas d-dimer exclusion ii (tm) , ref 30455, lot (b)(4).Customer stated a female, (b)(6) years old, presented with symptoms of fatigue.Blood sample had been taken, by the laboratory technician, at the patient's home.The first test results, performed by the reporting customer using the vidas d-dimer exclusion ii (dex2), on (b)(6) 2015, were: dex2 = 4660.45 ng/ml, white blood cells slightly elevated, crp 15.Based on these results the treating physician hospitalized the patient.

Manufacturer Narrative

Review of the corresponding batch qc records indicated no anomalies identified for vidas® ddex ii batch 1004051950.The product performed in accordance with specifications.The patient sample was not submitted by the customer.In the absence of sample return, it is not possible to perform testing to confirm the result or identifiy potential cause of the result observed by the customer.

• Brand Name: VIDAS® D DIMER EXCLUSION II (TM)
• Type of Device: VIDAS® D DIMER EXCLUSION II (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: 5169502
• MDR Text Key: 29009858
• Report Number: 3002769706-2015-00126
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112818
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2016
• Device Catalogue Number: 30455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• 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 Age: 86 YR