MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® FSH

Catalog Number 30407

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of invalid calibration and s1 results associated with vidas® fsh reference (30407).The customer opened the kit on (b)(6) 2018 and the results of the calibration are as follows: rfv s1 = 1583/1595 (normal range 1879-3355) second calibration was initiated and still gave an invalid s1 result = 1543/1566 (normal range 1879-3355).The customer reported delayed results for a patient greater than 24 hours due to the invalid calibration because the customer did not have another lot in inventory.The customer reported that the patient's serum was stored while waiting availability of another lot.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer in france reporting invalid calibration and s1 results associated with vidas® fsh (lot 1006080890).Tests performed during the in-house investigation, confirmed a decrease of the s1 signal for multiple lots.Cross-testing between vidas fsh assay strips and the solid phase receptacle (spr) demonstrated that the decrease of signal was related to the strips.The investigation has identified the exact well of the strip leading to the calibration issue.Furthermore, the root cause was linked to multiple lots of a raw material (horse serum) containing specific interfering antibodies.Field safety corrective action (fsca) 3834 was issued on 07mar2018 for vidas fsh lot 1006080890, instructing customers to destroy the impacted lot.A capa (corrective action preventive action) is ongoing to implement corrective and/or preventive actions.

• Brand Name: VIDAS® FSH
• Type of Device: VIDAS® FSH
• Manufacturer (Section D): BIOMERIEUX SA; 376, chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7365694
• MDR Text Key: 103798141
• Report Number: 3002769706-2018-00047
• Device Sequence Number: 1
• Product Code: CGJ
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 30407
• Device Lot Number: 1006080890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Removal/Correction Number: FSCA 3834
• Patient Sequence Number: 1