MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 XL BLUE MOD COLORM

Model Number 27228

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining terminations for multiple antimicrobials while testing twenty (20) isolates from different patients, in association with their vtk2xl blue mod colorm 220v instrument (ref 27228, serial (b)(4)).The customer indicated that the issue led to a delay >24 hours in reporting results.The terminations were observed while using the vitek 2 ast-n398 test kit (ref 423591) and the vitek 2 ast-n248 test kit (ref 413397) on this particular instrument.The customer provided lab reports and each lab report shows that the terminations were due to the "initial value being too low for analysis".The customer performed additional testing using the other vitek 2 instruments available in the laboratory, and did not observe any terminations when using the other instruments.A field service engineer (fse) visited the customer's site to evaluate the instrument.The fse identified an issue with the instrument's optics in which the optics magnet was not properly fixed and the optics were not closing correctly.The fse fixed the magnet, performed instrument checks, and processed engineering card tests.The instrument passed all testing and was returned to service.Since the fse service, no further terminations were observed.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in germany notified biomérieux of obtaining terminations for multiple antimicrobials while testing twenty (20) isolates from different patients, in association with their vitek® 2 xl instrument (ref (b)(4), serial (b)(6)).The customer indicated that the issue led to a delay >24 hours in reporting results.The customer performed additional testing using the other vitek 2 instruments available in the laboratory, and did not observe any terminations when using the other instruments.It determined that the terminations occurred on only one of their instruments.Instrument complaint (b)(4) includes a statement that indicates the magnet was glued in place, which is not a supported repair method.It was determined this ¿repair¿ was performed by the customer.The fse was asked to replace the transmittance optic and send it back for investigation.The transmittance optic was replaced and verified as operational by the fse.No further antibiotic terminations occurred.Instrument was released for routine use by the customer.The damaged transmittance optic was received and reviewed as part of the associated internal biomérieux investigation.The magnets on both sides of the transmittance optics were clearly encapsulated with glue.Any residual glue would cause an improper alignment of the optics emitter to the detector, resulting in test cards with initial value too low readings.The vitek 2 instrument user manual (041387-02) includes the following statements: caution: the user is encouraged to always contact biomérieux for any service activity.Caution: only authorized service technicians should perform any component installation or servicing of the instrument beyond normal operational and routine maintenance tasks.Contact biomérieux for any additional information or procedural direction.Conclusion: root cause ¿ the user liberally applied glue to both magnets on the transmittance optics (tx13), preventing the emitter and detector to properly close.The fse resolved the issue by replacing the transmittance optics.

• Brand Name: VITEK® 2 XL BLUE MOD COLORM
• Type of Device: VITEK® 2 XL BLUE MOD COLORM
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12366323
• MDR Text Key: 283162981
• Report Number: 1950204-2021-00070
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: S50510: S082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• 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: A
• Patient Sequence Number: 1