MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM

Catalog Number	416436
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from the united states notified biomérieux of false negative results associated with the vidas® lyme igm involving a patient sample.The customer indicated running the patient sample and getting negative result; however, the sample was sent to a reference lab where the western blot was positive for multiple bands.The customer reported the specimen they tested and the specimen the reference lab tested were obtained from the patient at the same time but were in different tubes.Serum was used for both tests.The customer indicated neither specimen is available for submission to biomérieux.A biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united states had notified biomérieux of false negative results associated with the vidas® lyme igm involving a patient sample.An internal biomérieux investigation was performed.The patient sample was not submitted for evaluation.The analysis of the batch history records for vidas lyme igm ii lot 1005662400 /180708 0 showed no anomaly during the manufacturing and control processes.The analysis of control charts of eight (8) internal samples, one (1) negative, two (2) equivocal, five (5) positive, on eight (8) vidas lyme igm ii batches (including the lot mentioned by the customer) showed that all the results were within specifications.Vidas lyme igm ii lot 1005662400 /180708 0 is in the trend of the other batches.The complaint laboratory tested five internal samples, four (4) positive and one (1) negative, on a retain kit of vidas lyme igm ii lot 1005662400 /180708 0.The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas lyme igm ii lot 1005662400 /180708 0 since its release.As it was not possible to get the sample, no further investigation could be performed.Vidas lyme igm ii lot 1005662400 /180708 0 performed within the expected specifications.

• Brand Name: VIDAS® LYME IGM
• Common Device Name: VIDAS® LYME IGM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 7076035
• Report Number: 3002769706-2017-00391
• Device Sequence Number: 939615
• Product Code: LSR
• UDI-Device Identifier: 03573026447151
• UDI-Public: 03573026447151
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2018
• Device Catalogue Number: 416436
• Device Lot Number: 1005662400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1