MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® FT4

Catalog Number 30459

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 02/15/2016

Event Type  Injury  

Event Description

A customer notified biomerieux of a discrepant result when using the vidas ft4 test kit.On (b)(6) 2016, the free thyroxine (ft4) result was 37.2 pmol/l.Due to patient symptoms and other test results, the physician ordered the serum to be sent to an external lab for additional testing.Results from the external lab were 16.5 pmol/l.The erroneous lab result was reported to the physician and as a result, the patient was incorrectly treated with neo-mercazole (carbinmazole).Furthermore, the patient underwent additional analyses including laboratory tests, ultrasound imaging and consultation with external physicians.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was conducted.The quality product laboratory tested one (1) hypothyroid sample, one (1) hyperthyroid sample and two (2) euthyroid samples on the retain for vidas® ft4 lot 1004345610.The results obtained for these four (4) samples were within specification.Compared to the results obtained during the release, the vidas® ft4 lot 1004345610 has not changed.The customer did not provide return sample; therefore, the investigation could not be continued and explanation regarding the customer's results could not be explained with certainty.Additional analysis concluded no other complaints registered for vidas® ft4 lot 1004345610 and no capa or non-conformity for vidas® ft4 lot 1004345610 linked to this complaint.Analysis of batch history records showed no anomaly during the control process.In conclusion, vidas® ft4 lot 1004345610 is performing as expected.

• Brand Name: VIDAS® FT4
• Type of Device: VIDAS® FT4
• 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: 5564774
• MDR Text Key: 42260804
• Report Number: 3002769706-2016-00063
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132058
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2016
• Device Catalogue Number: 30459
• Device Lot Number: 1004345610
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR