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

Catalog Number 30455

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a false negative result of <45 ng/ml associated with vidas d dimer exclusion ii (reference (b)(4)) involving a human plasma sample.The customer indicated the test was repeated and the result was 919.42 ng/ml.The customer reported there was no harm to the patient or erroneous treatment; however, the incorrect result was reported to a physician.The physician requested a repeat test be performed.The customer indicated there was no delay in obtaining results.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

An investigation into a false negative result event while using the vidas® d dimer exclusion ii test kit was performed.The customer obtained a negative result with the vidas® lyme igg test kit.Testing at a reference lab by western blot provided a positive result.The patient sample was not returned for investigational testing; therefore, this complaint could not be confirmed.Nine quality control samples near the cutoff value were run on retain samples from the lot involved within this complaint.All results were within expected values.A review of the batch production record and original quality control release testing was performed.No related anomalies or abnormalities were found.Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.

• Brand Name: VIDAS® D DIMER EXCLUSION II
• Type of Device: VIDAS® D DIMER EXCLUSION II
• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5888407
• MDR Text Key: 52722604
• Report Number: 3002769706-2016-00150
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/22/2016

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 Date: 09/29/2016
• Device Catalogue Number: 30455
• Device Lot Number: 1004366880
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1