MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS; VITEK® MASS SPECTROMETER

Catalog Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not received from customer.

Event Description

A customer in (b)(6) reported the occurrence of a misidentification of candida auris as candida haemulonii in association with the vitek ms identification system.The candida auris identification from the patient's sputum sample was confirmed by bruker ms and sequencing.The initial candida haemulonii result was reported to the physician.The customer states the correct result was delayed (unknown duration) due to the retesting activities.As the organism candida auris is not in the vitek ms knowledge base, the vitek ms cannot issue a result of candida auris.Typically, an organism that is not in the knowledge base will provide a result of "no identification." the customer submitted log file ((b)(6)) and calibration ((b)(6)) files.Upon simulation testing of the (b)(6) files by local support, the organism identification of candida haemulonii was obtained.Evaluation of the (b)(6) indicated the instrument fine-tuning criteria were out of specification.The local field service engineer (fse) visited the customer site to investigate the reported issue and successfully performed the fine-tuning procedure.Following fine-tuning, the fse processed the patient organism and achieved the expected result of "no identification" (candida auris is not in the vitek ms knowledge base).The on-site investigation determined the fine-tuning was not optimal.Following re-tuning, the instrument is functioning within specification.There is no indication or report from the hospital or treating physician to biomerieux that the occurrence led to any adverse event related to any patient's state of health.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MASS SPECTROMETER
• 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: 5877055
• MDR Text Key: 52185773
• Report Number: 3002769706-2016-00139
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/22/2015

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 Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2015
• Initial Date FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1