MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-N229 TEST KIT

Catalog Number 413146

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from (b)(6) notified biomérieux of the reporting of false susceptible amikacin results when performing antibiotic susceptibility testing (ast) for acinetobacter baumannii with the vitek® 2 ast-n229 test kit.The customer performed ast testing with the n229 card on acinetobacter baumanii, which has a limitation with amikacin.However, when reviewing the results, the customer overlooked the vitek 2 comment shown in red letters, "the result report regarding amk/acinetobacter baumannii has possibility of low credibility.Please test with other methods." the organism was reported as, "acinetobacter baumanii with resistance against 2 antimicrobials".These resistant results were as follows: carbapenem antibiotics: imipenem r (>=16), meropenem (>=16).New quinolone antibiotics: ciprofloxacin r(>=4), levofloxacin r (>=8).Following awareness of the above result, the customer promptly performed standard countermeasures to prevent the spread of infection.However, the acinetobacter baumanii infected another nine (9) patients (10 patients in total), which caused extension of their hospitalized periods.Amikacin had resulted as susceptible with vitek 2 with the limitation comment.No other test method had been performed.Then, the national institute of infectious disease gave direction that the customer perform alternative test methods (etest® and disc), which resulted as the acinetobacter baumanii isolate being resistant against amikacin.The customer reported that the patients had received treatment not with amikacin alone, but with multiple other antibiotics as well.In summary, multiple patients at the customer's site were infected by acinetobacter baumanii, which caused extension of their hospitalization periods.Infection did spread inside the hospital, but the hospital already assessed that the infection was not caused by the vitek 2 product.In reporting this instance, the customer fully understood that there was no malfunction with the instrument and/or the test cards used.It should be noted that for acinetobacter baumanii / amikacin, the package insert for this product specifies: "perform an alternative method of testing prior to report results for the following antibiotic/organism combinations." in addition, there was a comment as a warning on the lab report of the susceptibility test: "the result report regarding amikacin/acinetobacter baumannii has possibility of low credibility.Please test amikacin with alternative methods." a biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a customer in (b)(6) reporting false susceptible amikacin results when performing antibiotic susceptibility testing (ast) for acinetobacter baumannii with the vitek® 2 ast-n229 test kit.Alternative amikacin disk testing was resistant.The customer performed ast testing with the n229 card on acinetobacter baumannii, which has the following limitation with amikacin (an01n); perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination(s): amikacin (an01n): acinetobacter baumannii" based on the received lab reports, isolate audit records and bioart user change reports, the customer had originally obtained an isolate identification of acinetobacter baumannii complex which would have triggered bioart rule 5003 (which is the above limitation) to fire.However, the customer had disabled this rule.Instead, the customer had created a custom bioart rule which stated that amikacin results for acinetobacter baumannii need to be verified by an alternative method.However, their custom rule did not suppress the result from either analysis or reporting.When reviewing and approving the results, the customer overlooked their own vitek 2 comment with an internal comment which translates to; "the result report regarding amk/acinetobacter baumannii has possibility of low credibility.Please test with other methods." furthermore, the isolate was highly resistant.Additional antibiotic resistant results were as follows: -carbapenem antibiotics: imipenem r (>=16), meropenem (>=16) -new quinolone antibiotics: ciprofloxacin r(>=4), levofloxacin r (>=8) the technologist released the susceptible amikacin result prior to performing the alternative testing.Multiple patients at the customer's site were infected by acinetobacter baumannii, which caused extension of their hospitalization periods.Infection did spread inside the hospital, but the hospital already assessed that the infection was not caused by the vitek.In reporting this instance, the customer fully understood that there was no malfunction with the instrument and/or the test cards used.A review of quality records confirmed ast-n229 lot #6291045203 met final qc release criteria and the lot passed qc performance testing.To conclude, submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.However, for this organism/antibiotic version combination, there is a limitation (test by alternate method before reporting results).

• Brand Name: VITEK® 2 AST-N229 TEST KIT
• Type of Device: VITEK® 2 AST-N229 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: 8719203
• MDR Text Key: 148755145
• Report Number: 1950204-2019-00184
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172731
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2020
• Device Catalogue Number: 413146
• Device Lot Number: 6291045203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization