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

Model Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of misidentification results associated with vitek® ms instrument (reference 410895).The customer reported that a gram negative bacillus organism that was lactose positive, isolated from a patient urine sample, was identified as propionibacterium acnes twice.The customer suspected that the identification was incorrect, so they repeated vitek ms testing the following day.The final and correct identification was escherichia coli.The customer confirmed that no incorrect result was reported to the physician, but there was a delay of > 24 hours in reporting.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer from canada who reported a misidentification associated with vitek® ms instrument (reference 410895).The customer reported that a gram negative bacillus organism that was lactose positive, isolated from a patient urine sample, was identified as propionibacterium acnes twice.*conclusion on the system => the system was operational during the tests.=> the spot preparation was not optimal.The "all peaks number" from the calibrator strain is quite heterogeneous.=> there is a high difference between the "all peaks number" for the first and the second test which is not normal for the same sample.*conclusion on the identification: based on the complaint description, the expected identification is most likely escherichia coli.*suspected cause of the issue : the number of all peaks is low for the first test (43) compared to the second test (103).The "all peak numbers" variation between the two tests could be explained by: -either, a spot preparation variability -or spot made from a new subculture: better protein expression leading to more peaks (masses) detected in the spectra.

• Brand Name: VITEK MASS SPECTROMETER
• Type of Device: VITEK® MS¿
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7827370
• MDR Text Key: 119333488
• Report Number: 3002769706-2018-00171
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1