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

Model Number	416436
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8020790-2020-00011
• Device Sequence Number: 2235016
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 416436
• Device Catalogue Number: 416436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1