MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® CMV IGG ASSAY; VIDAS® CMV IGG ASSAU

Catalog Number 30204

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with vidas® cmv igg (reference 30204) related to false positive results.The customer reported the dilution factors of 1:429 which accounts for the high results.There is no indication or report from the laboratory or physician that the discrepant result led to an adverse event related to a patient's state of health.No incorrect information was reported to the physician because the results were identified as incorrect immediately.The customer reported there was approximately half an hour delay reporting results.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation concluded the following: the analysis of the batch history records showed no anomaly.There was no capa, nor non conformity for a similar issue in relation to the customer's anomaly.There was no other complaint for the same issue on the batch vidas (b)(6) lot 1005287390/170920-0.On march 09th, the product quality laboratory tested three internal samples ((b)(6)) on the retained kit vidas (b)(6) batch 1005287390/170920-0 on vidas pc.(b)(6), (b)(6) sample, target 3.1, the result was < 4 (b)(6).(b)(6), the same (b)(6) sample tested pure but with the dilution (1/428) entered in the vidas software.The result was (b)(6) (993 ua/ml).(b)(6), an equivocal sample, target 4.18, the result found: 4 ua/ml equivocal.(b)(6), a (b)(6) sample, tested pure the result was 176 ua/ml.(b)(6): the same (b)(6) sample tested pure but with the dilution (1/429) entered in the vidas software, the result was (b)(6) (77626 ua/ml).(b)(6): the same sample was tested with a manual dilution, the result is positive ( 232 ua/ml) consistent with the sample tested pure.The product quality laboratory reproduced the customer's anomaly.The concentrations are expressed in au/ml.Samples with (b)(6) concentrations > 400 au/ml should be reassayed after dilution by 1/4 in saline solution.If the dilution factor has not been entered when the work list was created (see user's manual), multiply the result by the dilution factor to obtain the sample concentration.For serological monitoring, to obtain an accurate serum titer, dilute the samples with concentrations > 150 au/ml in order to obtain a result ranging between 50-150 au/ml.Since no international standard is available for the determination of (b)(6), the vidas (b)(6) reagent is calibrated against collection sera.There is no drift linked to the reagent vidas (b)(6) lot 1005287390/170920-0.

• Brand Name: VIDAS® CMV IGG ASSAY
• Type of Device: VIDAS® CMV IGG ASSAU
• Manufacturer (Section D): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer (Section G): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6377068
• MDR Text Key: 69110204
• Report Number: 3002769706-2017-00042
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K920661
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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