MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CA 15-3®

Catalog Number 30429

Device Problem High Readings (2459)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On 9 october 2015 the customer, reported to biomerieux they had observed results for quality control testing was outside of the usual values (higher).The customer stated that the cqi test, was performed on (b)(6) 2015, using product ref (b)(4), vidas ca 15-3 30 tests, lot 1004085530, expiry date 03-jun-2016.The customer stated that on (b)(6) 2015, qc tests were re-performed using a different flacon.Results were within the expected value range, the lot number of the second flacon was not provided.The customer ran repeat vidas ca 15-3 tests for all patient samples that had been performed from the date of the last control to the (b)(6) 2015.Customer determined one patient (patient no.(b)(6)) sample from (b)(6), had indicated a ca level of 88.71.The result of 95.44 on (b)(6) was an increase from previous test results and indicative that treatment was not effective.Further testing, using a different lot (reference not known), was performed on the serum sample for this patient.Samples were thawed and tests indicated: sample from (b)(6) - result 81.38 compared to an initial test result of 88.71.Sample from (b)(6),101.74 compared to the initial test result of 95.44 reported to have been performed during this period.The laboratory has tried to obtain further information concerning patient therapy and treatment for patient no.(b)(6), but the patient has indicated that they will not provide additional information on this subject.

Manufacturer Narrative

Biomérieux internal investigation was conducted in association with a customer report of high and/or inconsistent quality control values.The customer did not submit the sample for investigation.The customer acknowledged they did not homogenize the sample after thawing, and did not vortex the calibrators or controls as instructed.Evaluation of the samples tested during biomérieux quality control activities indicate the product conformed to the specifications.No abnormalities were identified during manufacturing of the implicated lot.Since the customer did not submit the sample for testing, no further investigation activity is possible.

• Brand Name: VIDAS® CA 15-3®
• Type of Device: VIDAS® CA 15-3®
• 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: 5198916
• MDR Text Key: 30335889
• Report Number: 3002769706-2015-00136
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080469
• 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: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2016
• Device Catalogue Number: 30429
• Device Lot Number: 1004085530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1