MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN67 TEST KIT

Catalog Number	413399
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of false resistant results for cap survey strain (d-08) when testing with the vitek® 2 ast-gn67 test kit.The alcaligenes faecalis strain tested false resistant for piperacillin/tazobactam using gn67 lot 5870607403.Upon repeat testing, the customer obtained a susceptible result, which is the expected result for this survey strain.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
An internal investigation was performed for false resistant piperacillin/tazobactam (tzp) results for an alcaligenes faecalis cap survey strain (d-08) when testing with the vitek® 2 ast-gn67 test kit.Initial testing was resistant (mic>=128) and repeat was susceptible (mic <=4) which was the expected result for this survey strain.The us customer submitted their cap d-08 2018 alcaligenes faecalis ssp faecalis strain for piperacillin/tazobactam (tzp) evaluation.Both the first and second swab isolates were submitted for evaluation.The customer's two cap d-08 strains and the internal biomerieux cap d-08 survey strain were subbed on tsab and identifications were confirmed.Testing was performed on the customer lot and a random lot of ast-gn67 cards.Broth microdilution (bmd), the reference method for tzp (tzp03n), was also performed.911744 (customer's d-08 strain- swab 1): both cards tested gave a resistant mic>=128.Bmd gave a susceptible mic<=4.911745 (customer's d-08 strain- swab 2): both cards tested gave a resistant mic>=128.Bmd gave a susceptible mic<=4.911704 (internal d-08 strain): customer card lot gave a susceptible mic<=4, while random lot gave an intermediate mic=64.Bmd gave a susceptible mic<=4.Card and reference method are in agreement for the customer lot, but the random lot results are a minor category error when compared to reference.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.The investigation concluded this is an atypical strain.

• Brand Name: VITEK® 2 AST-GN67 TEST KIT
• Common Device Name: VITEK® 2 AST-GN67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7902782
• Report Number: 1950204-2018-00389
• Device Sequence Number: 11115021
• Product Code: LON
• UDI-Device Identifier: 03573026398453
• UDI-Public: 03573026398453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113200
• 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): 11/19/2018

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: 07/26/2019
• Device Catalogue Number: 413399
• Device Lot Number: 5870607403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1