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

Model Number	417401
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 false negative results for three patients when using vidas® lyme igg ii 60 tests (ref.417401, lot 1007649070).For three patients, the customer obtained negative results when using vidas lyme igg ii 60 tests, lot 1007649070 with results respectively at 0.02, 0.03 and 0.04.The same samples tested with western blot igg assay showed positive results.Sample (b)(6), rfv:28.,tv: 0.02, result:negative.Sample (b)(6), rfv:30, tv:0.03, result: negative.Sample (b)(6): rfv , tv:0.04, result negatvie.Western blot igg sample (b)(6) positive.Sample (b)(6) positive.Sample (b)(6) positive.There is no indication or report from the laboratory that the false negative results led to any adverse event related to any patient's state of health.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of false negative results for three patients when using vidas® lyme igg ii 60 tests (ref.(b)(4), lot 1007649070).No samples were submitted by the customer for the investigation.A complaint review did not identify any other occurrences of false negative results obtained for this lot number.Review of production records revealed no anomalies during manufacturing, control, and packaging processes for this lot.The complaint laboratory tested 8 internal samples with 6 different lots including the lot used by the customer.Analysis of control charts show that all results are within specifications and the customer's lot is in trend of the other lots evaluated.Additionally, 4 internal samples were tested with a retain sample of the customer's lot and all results were within expected specifications.There was no drift observed.Without the customer's samples, further investigation cannot be completed and the root cause for the customer's issue cannot be determined.According to the investigational testing performed, vidas lyme igg ii ref 417401 lot 1007649070 / 201226-0 is within expected performance.See h10 for addtl mfg narrative.

• Brand Name: VIDAS® LYME IGG II 60 TESTS
• Common Device Name: VIDAS® LYME IGG II 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9920382
• Report Number: 8020790-2020-00038
• Device Sequence Number: 2320127
• Product Code: LSR
• UDI-Device Identifier: 03573026458270
• UDI-Public: 03573026458270
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141133
• 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): 05/04/2020

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 Expiration Date: 12/26/2020
• Device Model Number: 417401
• Device Catalogue Number: 417401
• Device Lot Number: 1007649070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1