MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN69 TEST KIT

Catalog Number	413400
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported false resistant carbapenem results for four (4) strains from patient urine samples, in association with the vitek® 2 ast-gn69 test kit (lot 5890803203).On (b)(6) 2018, the customer started obtaining resistant results for multiple drugs on the ast-gn69 card for multiple patients.Upon repeat testing with kirby-bauer, the results were susceptible.The customer reported that this resistance pattern continued for days with lot 5890803203.Another lot was then used on (b)(6) 2018 without issue.Patient strains impacted: f71157 - escherichia coli; s54418 - klebsiella pneumoniae ssp pneumoniae; s56450 - escherichia coli; s56172 - proteus mirabilis.The customer reported that ast-gn69 lot 5890803203 originally passed qc on (b)(6) 2018, but weekly qc on (b)(6) 2018 failed several drugs.The customer stated they did not report the incorrect vitek results, as they repeated vitek with kirby bauer and reported the consistent results.The customer stated there was no known impact to patient treatment.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
The investigation was initiated in response to customer complaints reporting falsely elevated mics for carbapenem drugs on particular lots of gram negative antimicrobial susceptibility (ast-gn) test cards.Examination of retained stock and product returned from customer sites showed that some card pouches within the implicated lots had top seals that could be pulled open with minimal effort.The weak top seals allowed the card to be exposed to moisture/humidity during storage leading to deterioration of drugs in the card wells and falsely elevated mics.Carbapenems are among the most moisture-sensitive drugs, so they will be the first drugs impacted when pouch integrity is breached.The investigation determined that impacted cards were pouched on the same equipment, poucher 1.Extensive reviews of manufacturing records, retained card stock, and customer complaint data isolated the issue to lots manufactured from 10aug2018 to 29aug2018.Since it is typical for more than one poucher to be used for packaging a card lot, cards pouched on other pouchers are not impacted by this issue.For cards pouched using poucher 1, the incidence of the ineffective top seal issue varies.This investigation identified potential sources of variation in the pouch sealing process that contributed to the occurrence of ineffective top seals.Actions were created related to the pouchers to achieve a more consistent sealing process.Actions were also taken to add inspections for the pouch top seal during production.Further actions will be implemented to add seal inspections that will detect the type of weak top seals identified in this investigation in the final lot release qc.A field safety corrective action (fsca 4215) was issued 11jan2019 and sent to customers who received any of the card lots manufactured using poucher 1 during the implicated timeframe.The communication included instructions for locating the poucher number on the card pouch and for inspecting the pouch top seal to identify pouches with ineffective seals.

• Brand Name: VITEK® 2 AST-GN69 TEST KIT
• Common Device Name: VITEK® 2 AST-GN69 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8090329
• Report Number: 1950204-2018-00536
• Device Sequence Number: 13879583
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2019

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 Expiration Date: 02/07/2020
• Device Catalogue Number: 413400
• Device Lot Number: 5890803203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 4215
• Patient Sequence Number: 1