MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® RUB IGG II ASSAY

Catalog Number 30221

Device Problem False Negative Result (1225)

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

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a false negative result obtained with the product vidas rub igg ii (ref.30221) using the instrument vidas 3.The customer obtained a negative result on vidas (7 ui/ml) on (b)(6) 2015 for a pregnant woman with the vidas rub igg lot 1003788010 (expiration date 18-jan-2016).The technique cobas gave a positive result at 17.41 on the same sample.The patient is a pregnant woman at 6-7 weeks of pregnancy.The customer repeated the same sample on (b)(6) 2015 using the kit vidas rub igg lot 1003903030 (expiration date 16-mar-2016) and the result was still negative at 7 ui/ml.The results provided to the clinician were the negative results obtained on vidas.The clinician did not agree with these results because the patient was vaccinated.The vidas rub igg ii (ref.30221) is not sold in the us; however, a similar product vidas rub igg (ref.30226) is sold.There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to a patient's state of health.Culture submittal has been requested by biomerieux for internal investigation.Biomerieux internal investigation will be conducted.

Manufacturer Narrative

Biomérieux investigation was conducted.Evaluation of the vidas® rubella igg ii (lot 1003903030) indicates no anomaly identified during manufacturing qc.There was no non-conformity related to the customer's issue.Investigation testing included: customer submitted sample using the customer submitted rubella igg ii kit.Customer submitted sample using in-house retain kits from customer lot.Customer submitted sample using in-house retain kits from three (3) different rubella igg ii lots.Customer submitted sample using in-house retain kits from a rubella igg lot (used in usa).The submitted sample was found to be "negative" in all cases.In addition, internal qc samples (positive and equivocal) were tested with retain kits of the customer lot.Kit performance was in accordance with specifications.Testing was performed via biorad technique (platelia rubella igg ref 72850); the result was "equivocal" three (3) times.It seems that there is anti-rubella ab in the serum, but with a rate below the vidas® system's technical detection threshold.The package insert for vidas® rbg ii indicates sensitivity is not 100%, evidenced in the following excerpt : "relative sensitivity was established for each study in comparison with two commercialized reagents.Study a: sensitivity: 97.87% (95 % confidence interval: 94.57% - 99.18%).Study b: sensitivity: 95.45% (95% confidence interval: 91.74% - 97.54%).Since a few rare cases of reinfection with rubella have been reported in previously vaccinated or infected women, certain authors have suggested revaccinating subjects at risk when the level of anti-rubella igg is less than 25 iu/ml.".

• Brand Name: VIDAS® RUB IGG II ASSAY
• Type of Device: VIDAS® RUB IGG II 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 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5099932
• MDR Text Key: 26844691
• Report Number: 3002769706-2015-00100
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K080766
• 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: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2016
• Device Catalogue Number: 30221
• Device Lot Number: 1003903030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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