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

Catalog Number 30319

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux that they have observed false negative results when using the products vidas® lyme igm (ref.30319) lot 1005810050 and vidas® lyme igg (ref.30320) lot 1005816250.The patient is a (b)(6) male with complaints of joint pain.The patient did not remember having a tick bite and erythema migrans was not observed.On (b)(6) 2017, the customer tested the patient's sample on both vidas® lyme igm and vidas® lyme igg.The results obtained were negative with the following values: ·lyme igg: 0.10, ·lyme igm: 0.02.The patient's sample had been tested with western blot technique (borrelia euroline-wb igg).The results were positive with 3 bands for igm and 4 bands for igg.The customer reported that patient results were affected and wrong results were reported to a physician.The customer stated there was no delay in reporting results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) had reported to biomérieux that they have observed false negative results when using the products vidas® lyme igm (ref.30319) lot 1005810050 and vidas® lyme igg (ref.30320) lot 1005816250, whereas positive results were obtained using euroline western blot.An internal biomérieux investigation was performed.The analysis of the batch history records for vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 showed no anomaly during the manufacturing and control processes.The analysis of control charts of 12 internal samples (1 negative, 4 equivocal, 7 positive) on 15 vidas lyme igm batches and 10 internal samples (3 negative, 7 positive) on 7 vidas lyme igg batches (including lots mentioned by customer) showed that all the results are within specifications.Vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 are within the trend of the other batches.The complaint laboratory tested five internal samples (1 equivocal, 4 positive) on the retain kit vidas lyme igm lot 1005810050/180614-0 and five other internal samples (1 negative, 4 positive) on the retain vidas lyme igg lot 1005816250/180622-0.The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas lyme igm lot 1005810050/180614-0 and vidas lyme igg lot 1005816250/180622-0 since their release.The negative result obtained by the customer was reproduced both on igg and igm and confirmed with another technique (immunoblotting : no visible band or band inferior to the cut off).This result confirmed the vidas interpretation, and there is no reconsideration of the vidas igm and vidas lyme igg performances.Final conclusion : according to all the data mentioned above, vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 are within the expected specifications.No other complaint was recorded for a sensitivity issue on vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0.

• Brand Name: VIDAS® LYME IGM
• Type of Device: VIDAS® LYME IGM
• Manufacturer (Section D): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7074792
• MDR Text Key: 94570736
• Report Number: 3002769706-2017-00388
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K122979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Catalogue Number: 30319
• Device Lot Number: 1005810050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR