MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM

Catalog Number 30319

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 (b)(6) reported to biomérieux a false negative result in association with the vidas® lyme igm test for a (b)(6) patient with heart problems, whereas the doctor suspected borreliosis.The results were: vidas® lyme igm - negative (tv 0,05), vidas® lyme igg - negative ( tv 0,01).In addition, a western blot (wb) lyme igm test was performed.The result of the wb igm was positive with strong positive reaction for the ospc and p41 bands, and weak positive reaction ospc bb.The physician and patient were informed about both results (negative vidas® tests and positive wb test).There is no indication or report that the discrepant result led to any adverse event related to the patient's state of health.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation concluded the following: this complaint is related to a negative result vidas lyme igm lot 1005181000/170906-0 while the result is positive with western blot test (euroimmun).There is no other complaint registered on the vidas lyme igm lot 1005181000/170906-0 for sensitivity issue.There are no capa and nor non conformity for vidas lyme igm 1005181000/170906-0 linked to this complaint.The analysis of the batch history records shows no anomaly during the manufacturing and control process.The analysis of the control card of vidas lyme igm lot 1005181000/170906-0 shows that there is no significant variation for this lot compared to the other lots.On january 20th, the product quality laboratory tested five internal samples on the retain kit vidas lyme igm batch 1005181000/170906-0 on vidas pc, the results obtained are similar to the results obtained during the release of the batch.On february 10th, the product quality laboratory tested two return customer's samples (sampling of (b)(6) 2016 and sampling (b)(6) 2017) on the retain kit vidas lyme igm lot 1005181000/170906-0 and retain kit vidas lyme igg lot1005160750/170906-0 as the customer done.The results obtained for the 2 samples tested for vidas lyme igm lot 1005181000/170906-0 are negative and negative with vidas lyme igg lot 1005160750/170906-0.We reproduced the customer's result.The product quality laboratory tested the 2 samples with lymecheck igm /igg (western blot technique), the results obtained are negative for the 2 samples.We obtained a p41 band but it is not specific band for lyme.The results found on lymecheck igm is in agreement with the results found on the vidas lyme igm batch 1005181000 / 170906-0.The 2 samples sent to an external laboratory and they tested another lia technique (diasorin) and another western blot technique : mikrogen the results found on immunoblot-mikrogen are negative and in accordance with vidas results.The results found with lia method are found equivocal or low positive.The investigation showed that for the 2 samples return, the results are negatives with vidas lyme igm lot 1005181000/170906-0 as the 2 western blot techniques tested mikrogen and lymecheck.The performance of vidas lyme igm lot 1005181000/170906-0 are within expected specifications.

• Brand Name: VIDAS® LYME IGM
• Type of Device: VIDAS® LYME IGM
• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6210729
• MDR Text Key: 63615907
• Report Number: 3002769706-2016-00532
• Device Sequence Number: 1
• Product Code: LYR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K141133
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/06/2017
• Device Catalogue Number: 30319
• Device Lot Number: 1005181000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• 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