MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS CMV IGG ASSAY

Catalog Number 30204

Device Problem False Positive Result (1227)

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

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

A sample of the patient's blood was received by biomerieux and was tested on retain samples from (b)(6).The sample tested positive for cmv igg on the retain sample.A review of the manufacturing batch records was performed and no nonconformances or anomalies were found.The sample was also tested with the following lots yielding the : (b)(6).A capa, (b)(4), has been initiated to further investigate the root cause of the discrepancies between lots.

Event Description

A customer contacted biomerieux regarding a discrepant result with the vidas cmv igg test.Vidas cmv igg is an automated quantitative enzyme immunoassay for use on the vidas family instruments for the quantitative measurement, of anti-cytomegalovirus igg (cmvg) in human serum, using the elfa (enzyme linked fluorescent assay) technique.The test is positive if the value is >= 6 ua/ml.A patient sample was tested on (b)(6) 2015 using the vidas cmv igg test and the result was positive at 9 ua/ml.Another chemioluminescence method gave a negative result (<0.150 ui/ml for a threshold of 0.5 ui/ml).A new sample of the same patient was tested on (b)(6) 2015 using the same lot and the result was still positive at 10 ua/ml.Another chemiluminescence method gave a negative result (<0.150 ui/ml for a threshold of 0.5 ui/ml).The result of the antibodies igm was negative with two techniques.

Manufacturer Narrative

The patient sample collected on (b)(6)-2015 was sent to biomérieux to be tested.The (b)(6) result was reproduced on lot 1003035170 used by the customer.The sample was also tested with the additional lots and the results obtained are summarized below: (b)(6).A review of the manufacturing record was performed and no anomalies or abnormal incidents were noted to have occurred during manufacturing of this lot.As the lot is expired, no additional investigations can be performed.There is no corrective or preventive actions associated to the reported complaint because there is no evidence of a sensitivity issue or product malfunction with the referenced lot 1003035170.The root cause of the discrepant positive results obtained by the customer could not be determined although it could not rule out a sample related effect.In mitigation of the discrepant positive results obtained by the customer, vidas cmvg instruction for use - limitation of the method - reads: 1) the vidas cmvg assay results should be interpreted taking into account the clinical symptoms and the medical analysis results from other tests (e.G.Detection of anti-cmv igm in case of primary infection).2) interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient history, and the results of any other tests performed.There is no indication that lot 1003035170 was outside performance expectations; therefore, no further action is required.

• Brand Name: VIDAS CMV IGG ASSAY
• Type of Device: VIDAS CMV IGG ASSAY
• 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 6928 0; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4851454
• MDR Text Key: 22952079
• Report Number: 3002769706-2015-00048
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K920661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2015
• Device Catalogue Number: 30204
• Device Lot Number: 1003283600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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