MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT; VITEK 2 AST-GN73 TEST KIT

Catalog Number 413404

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problem Death (1802)

Event Date 01/01/2014

Event Type  Death  

Event Description

A customer reported a discrepant trimethoprim/sulfamethoxazole (sxt) result for stenotrophomonas maltophilia on the vitek 2 ast-gn73 test kit.Isolates from a pt with stenotrophomonas maltophilia tested resistant to sxt on the vitek 2 (mic greater than or equal to 160) for three samples (two respiratory, one tissue).The pt was responding to previously prescribed sct treatment, so the original (collected before sct treatment) isolate samples were sent to (b)(6) for confirmatory testing.(b)(6) reported results of susceptible to sxt (mic less than or equal to 2).The customer repeated the sample testing using the vitek 2 ast gn73 test kit, and again received results of r (resistant) to sxt, which is when they reported the complaint to biomerieux for further investigation.Internal investigation confirmed the customer's resistant sxt result by the vitek 2.On (b)(6) 2014, the customer indicated the pt had been removed from sxt due to the vitek 2 report of organism resistance to sxt.It is unk what therapy was applied following the removal of sxt treatment.The pt's condition subsequently worsened and she passed away sometime during the month of (b)(6) 2014.The customer refused to provide details regarding pt demographics, pre-existing conditions, diagnosis, other treatments, or time-line of events including the date of death or cause of death.However, since the customer indicated the pt had passed away following a treatment decision based on the vitek 2 ast-gn73 sxt result, the vitek 2 ast-gn73 test kit cannot be eliminated as a potential contributing factor in the pt's death.Biomerieux has contacted the customer via telephone/email on multiple occasions and the local sales representative has visited the customer site in an attempt to obtain details of the event.In each case, the customer indicated the issue is being investigated by the hospital's risk management department and no information can be released until the investigation is completed.On (b)(6) 2014, the customer notified biomerieux that the hospital's risk management team determined the pt's death was not related to removal of the pt from sxt therapy; the pt was also exhibiting a favorable response to the new antibiotic, though the name of the antibiotic was not provided.Biomerieux investigation: sxt testing of the three submitted isolates included a test kit from the same lot of ast-gn73 test kits as that used by the customer, a test kit from a random lot, and broth micro-dilution (bmd), the reference method for sxt.For all three isolates, both lots of ast-gn73 cards gave resistant results of greater than or equal to 320 and bmd gave susceptible results of less than or equal to 20.The investigation reproduced the results as reported by the customer.

Manufacturer Narrative

Review of complaint date from june 2012 to june 2014 identified (b)(4).Of the (b)(4) complaints that where received over the past two years, (b)(4) resulted in internal investigation and (b)(4) investigations reproduced the (b)(4) results seen by the customer ((b)(4)).The complaints were reported against various card types and lots.Card types and lot numbers against which sxt vs stenotrophomonas maltophilia complaints were received in the past two years are listed.(b)(4).For (b)(4) test kits distributed (sum of all lots referenced) to customers, there have been (b)(4) complaints and (b)(4) internal investigations, (b)(4) of which reproduced the discordant results observed by the associated customer.Based on the investigation results, biomerieux will investigate the feasibility of moving stenotrophomonas maltophilia to its own knowledge base.However, there is currently no fda indication for stenophomonas maltophilia with sxt for the vitek 2 system; biomerieux performance claims for fda/clsi do not include stenotrophomonas maltophilia.Though it is possible the customer has performed some method of internal validation of this antimicrobial/organism combination for their own use, it appears the customer is using sxt in an off-label manner for stenotrophomonas maltophilia.

• Brand Name: VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT
• Type of Device: VITEK 2 AST-GN73 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; hazelwood MO
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 3975040
• MDR Text Key: 4889302
• Report Number: 1950204-2014-00007
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2015
• Device Catalogue Number: 413404
• Device Lot Number: 593315340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death