MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-N223 TEST KIT

Catalog Number 413110

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2018, a customer in (b)(6) notified biomérieux of false resistant imipenem results when performing antibiotic susceptibility testing with the vitek® 2 ast-n223 test kit.Initial testing obtained an imipenem mic >/= 16 (resistant) for an escherichia coli isolate.The customer performed retesting with agar diffusion and obtained imipenem susceptible.The customer reported that there was no patient harmed or treated incorrectly due to the discrepant result.The customer stated there was no delay in reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux 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-N223 TEST KIT
• Type of Device: VITEK® 2 AST-N223 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8192290
• MDR Text Key: 131310122
• Report Number: 1950204-2018-00729
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Catalogue Number: 413110
• Device Lot Number: 6230811103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FSCA 4215
• Patient Sequence Number: 1