MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® VARICELLA-ZOSTER IGG 60 T; VIDAS VARICEL. ZOSTER IGG 60 T - 30217

Model Number	30217
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 (b)(6) notified biomérieux of a false negative varicella-zoster igg (vzg)result in association with the vidas® varicella-zoster igg 60 t (ref 30217).The specific lot number was not provided.There is no indication or report from the laboratory that the false negative vzg result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united kingdom reported a false negative varicella-zoster igg result in association with vidas® varicella-zoster igg 60 t ref 30217) the lot was not specified.The impacted lot number and patient reports were requested but not provided.Biomerieux reviewed performance fault codes, capa, and nonconformities in association with vidas® varicella-zoster igg 60 t (ref 30217).This review did not identify any associated capa nonconformity associated with false negative results.Biomerieux performed internal testing using four (4) positive samples on batches that expire in 2019 and 2020.All samples tested obtained within specification results.The root cause could not be determined as the impacted lot number and sample were not provided.Vidas® varicella-zoster igg 60 t (ref 30217) is performing within specification.See section h10.

• Brand Name: VIDAS® VARICELLA-ZOSTER IGG 60 T
• Common Device Name: VIDAS VARICEL. ZOSTER IGG 60 T - 30217
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9433916
• Report Number: 8020790-2019-00072
• Device Sequence Number: 18950001
• Product Code: LFY
• UDI-Device Identifier: 03573026064518
• UDI-Public: 03573026064518
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 30217
• Device Catalogue Number: 30217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1