MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS CMV IGG

Catalog Number 30204

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/24/2016

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with the vidas® cmv igg.The customer reported that on (b)(6) 2016, they observed a quality control (qc) out of range when using the vidas® cmv igg.Following this, the customer tested a known positive patient serum sample.The result shifted from positive to equivocal.Patient sample: test 1 - result 8ua/ml positive; test 2 - result 5 ua/ml equivocal.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of discrepant results associated with vidas® cmv igg.An internal biomérieux investigation was conducted.The analysis of the quality and batch records for vidas® cmv igg lot 1005099130/170705-0 showed no other complaints, issues or nonconformities in association with the lot.A test was conducted for 8 internal samples on vidas® cmv igg lot 1005099130/170705-0.All samples conformed to the expected results and specifications.A review of quality control records on several batches of vidas® cmv igg showed all samples are within the expected ranges, and lot 170705-0 is in the trend as the other lots.The instructions for use (package insert) indicate the following: -it is recommended to confirm equivocal results using a second sample.-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).The investigation concluded the vidas® mv igg lot 1005099130/170705-0 performed as intended.

• Brand Name: VIDAS CMV IGG
• Type of Device: VIDAS CMV 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; st. louis, MO 63042
• MDR Report Key: 6180566
• MDR Text Key: 62544572
• Report Number: 3002769706-2016-00520
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2017
• Device Catalogue Number: 30204
• Device Lot Number: 1005099130
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1