MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 COMPACT 30; VITEK 2 COMPACT 30 - 27530

Model Number	27530
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 biomériex of false resistant results and delays in reporting results for patient isolates in association with the vitek® 2 compact 30 (ref 27530, serial (b)(4)).The customer stated that the majority of their patient isolates were obtaining resistant results on the vitek® 2.There is no indication or report from the laboratory that the false resistant results or delays led to any adverse events related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation in response to a customer complaint of out of range high results in association with the vitek® 2 compact 30 (ref.27530, serial (b)(6)).A biomérieux field service engineer (fse) visited the customer site and performed the following actions: optical check - cleaning of the reading heads.Exchange of the roller flat springs - tread test hcb ok, tx1>4000, tx3>3700 - launched eng9 card in control the fse noted the optics of the instrument were dirty and cleaned them.The springs were also replaced but not retained.Based on the available data the root cause could not be established.Optics issues, user issue and reagent issues were identified as potential causes.See section h10.

• Brand Name: VITEK® 2 COMPACT 30
• Common Device Name: VITEK 2 COMPACT 30 - 27530
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9547285
• Report Number: 1950204-2020-00002
• Device Sequence Number: 19439712
• Product Code: LON
• UDI-Device Identifier: 03573026136789
• UDI-Public: 03573026136789
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050002
• 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): 03/12/2020

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: 27530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1