MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® MEASLES IGG

Catalog Number 30219

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer in the (b)(6) contacted biomerieux to report the occurrence of false negative and false equivocal results in association with the vidas measles igg assay.Testing of specimens by reference laboratory obtained a result of positive.The customer stated that two (2) results from the referenced lot were confirmed as false negative.Initial results were 0.37 and 0.49 indicating a negative which were later confirmed as a positive.The customer indicated delays of between 10-14 days when a false negative is reported, which will delay treatment as the customer is sending all negatives to a different hospital.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report the occurrence of false negative and false equivocal results in association with the vidas® measles igg assay.An internal biomérieux investigation was performed.Results are as follows: the customer's sample was not submitted.Since october 2015, there is no other complaint related sensitivity problem for vidas® msg batch 1004802610 / 170302-0.There is no capa, nor non conformity for a similar issue in relation to the customer's complaint.The analysis of the batch history records showed that four (4) samples were out of range but these samples were found within their interpretation.During the quality control process, a specificity control was performed on 28 negative sera and 54 positive sera.All sera were found within their specifications.The analysis of the control card of each sample tested showed that vidas® msg batch 170302-0 was in the trend with the other batches.The quality product laboratory tested two (2) internal negative and two (2) internal positive samples on the retain kit vidas® msg batch 1004802610 / 170302-0.The results obtained for the four (4) samples were within their specifications.The performance of vidas® msg batch 170302-0 are within the expected specifications indicated in the package insert.

• Brand Name: VIDAS® MEASLES IGG
• Type of Device: VIDAS® MEASLES IGG
• 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: 5963708
• MDR Text Key: 55161018
• Report Number: 3002769706-2016-00343
• Device Sequence Number: 1
• Product Code: LJB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: CL. I 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2017
• Device Catalogue Number: 30219
• Device Lot Number: 1004802610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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