MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM II

Catalog Number 416436

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in the united states reported to biomérieux a false negative result for six (6) samples in association with vidas® lyme igm ii test kit.The vidas® lyme igm test result was negative for all 6 samples, although 2 were known by the customer to be positive.All samples were positive by western blot, and the bands present for the 2 known positives were band 23 (osp c) and band 41.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux investigation was conducted.A review of quality records for vidas® lyme igm ii lot 1004988230 confirmed the lot met the manufacturing criteria and there were no similar issues.Five (5) reserve samples were tested from the lot.(target: vt : 1.22, 0.22 , 2.42, 0.01, and 0.01) all test results for each sample were within the expected specifications.According to the wb package insert (viramed biotech ag - borrelia b31 igm virastripe®), it used the strain borrelia burgdorferi sensu stricto (american strain borrelia).The vidas® lyme igm ii used recombinant antigens from borrelia burgdorferi sensu stricto, b afzelii and b garinii.The vidas® lyme igm ii package insert states: "limitations of the method": a negative result in the vidas® lyme igm ii assay does not rule out the possibility of b.Burgdorferi infection in a patient.Patients in early stages of infection or who have undergone antibiotic therapy, may not produce measurable antibodies.Patients with clinical history and/or symptoms suggestive of lyme disease, but with negative test results, should be reported as "no detectable antibodies to b.Burgdorferi".A second specimen should be collected in 4-6 weeks.Note: it is estimated that in 50% of subjects, in the primary stage of disease, antibody levels in blood remain below the detectable threshold (10).Further investigation is not possible without the customer isolate.The vidas® lyme igm ii lot 1004988230 performed within specifications.

• Brand Name: VIDAS® LYME IGM II
• Type of Device: VIDAS® LYME IGM II
• 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 ; 3147317301
• MDR Report Key: 6226239
• MDR Text Key: 64019833
• Report Number: 3002769706-2017-00001
• Device Sequence Number: 1
• Product Code: LYR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2017
• Device Catalogue Number: 416436
• Device Lot Number: 1004988230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• 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: N
• Patient Sequence Number: 1