MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM II 60 TESTS

Model Number 416436

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

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

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of obtaining a false negative result for patient sample in association with the vidas® lyme igm 60 tests (ref 416436, lot number not specified).The customer tested the patient sample using vidas® lyme igm 60 tests which obtained a negative result.The customer also tested the sample using western blot and sofia test method, both assays yielded a positive result.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of obtaining a false negative result for patient sample in association with the vidas® lyme igm 60 tests (ref 416436, lot 1007334400).The customer was unable to submit the sample for investigational testing.There have been no other complaints registered for this type of issue for this lot.An internal study was conducted with internal samples on seven (7) different batches of vidas lyme igm ii including the customer¿s lot (1007334400).The analysis of the control charts showed that all results were within specifications, customer¿s lot was in the trend of the other lots.Two (2) negative samples and three (3) positive samples were tested on lot 1007334400.All results were compliant to specifications.Without the customer's sample, no root cause was able to be established.The internal study did not identify any issue with the customer's lot of vidas® lyme igm 60 tests (ref 416436, lot 1007334400).

• Brand Name: VIDAS® LYME IGM II 60 TESTS
• Type of Device: VIDAS® LYME IGM II 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9652884
• MDR Text Key: 207751830
• Report Number: 8020790-2020-00011
• Device Sequence Number: 1
• Product Code: LSR
• UDI-Device Identifier: 03573026447151
• UDI-Public: 03573026447151
• Combination Product (y/n): N
• PMA/PMN Number: K122979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 416436
• Device Catalogue Number: 416436
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1