MAUDE Adverse Event Report: BIOMERIEUX, S.A. VIDAS® PROLACTIN

Catalog Number 30410

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2017

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a discrepancy when correlating results between the vidas® prolactin test kit ((b)(4)) and chemiluminescence methods.A patient serum sample was tested (b)(6) 2016 with vidas® and produced a result of 85.53 ng/ml.Due to this result the patient started treatment with cabergoline (0.5 mg) in (b)(6) 2016.On (b)(6) 2016 a prolactin control was performed and the result was 35.13 ng/ml.The customer reported the next control test was (b)(6) 2017 and the result was 75.18 ng/ml with vidas®.This same sample was then processed by chemiluminescence and the result was 0.7 ng /ml (rv: 4.79-23.3).A new serum sample was tested (b)(6) 2017 with vidas® and the result was 74.03 ng/ml.This sample was processed in two laboratories by chemiluminescence and the results were <2 ng/ml (rv: 4.79-23.3); and 0.5 ng/ml (rv:1.9-25).Another sample tested (b)(6) 2017 gave a 70.22 ng/ml result.Patient serum samples were then tested with mini vidas® and the results of the samples were 31.40 and 31.86 ng/ml, respectively.The customer's monthly qcv and prolactin external quality control results were as expected.The customer stated the vidas® results do not correlate with the clinical history of the patient.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from colombia reported discrepant values for the vidas® prolactin test kit when compared to the chemiluminescence method, for prolactin control samples from a patient that were tested on (b)(6) 2017.The customer did not provide a sample or test report for evaluation.An investigation was performed.A review of quality records confirmed the vidas® prolactin test kit (lot 1005172980) met specifications.The quality product laboratory has tested a calibration sample and six internal samples on a retained vidas® prolactin test kit (lot 1005172980).The results were: (b)(6).The results obtained for the calibration sample and six internal samples were within the specifications.The analysis of the control charts plus one additional sample of high concentration ([123.5-199.54] ng/ml 3is) showed that vidas® prolactin test kit (lot 1005172980) was within the trend of the other batches.The vidas® prolactin test kit (lot 1005172980) performed as intended.The customer did not provide a sample or information related to the other method used, thus further investigation is not possible.

• Brand Name: VIDAS® PROLACTIN
• Type of Device: VIDAS® PROLACTIN
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6587662
• MDR Text Key: 75858362
• Report Number: 3002769706-2017-00126
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Catalogue Number: 30410
• Device Lot Number: 1005172980
• Other Device ID Number: 03573026064969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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