MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-GN70 TEST KIT

Catalog Number	413401
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 discrepant susceptibility results for cap survey strain (d-08) when testing with the vitek® 2 ast-gn70 test kit.The expected result for this ungraded survey alcaligenes faecalis strain is susceptible.On initial testing, the strain tested false resistant (mic >=128) for piperacillin/tazobactam using vitek 2 ast-gn70, lot 5900678403.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
A customer in the us notified biomérieux of false resistant results for cap survey strain (d-08) when testing with the vitek 2 ast-gn70 cards.The alcaligenes faecalis ssp.Faecalis strain resulted in mics => 128 (r), <= 4 (s), and 64 (i) for piperacillin/tazobactam (tzp) with their original strain and 64 (i), <= 4 (s) with their back-up swab.The expected result was susceptible.The strains were submitted for investigation.Investigation details: the customer's submitted strains and the biomerieux internal cap d-08 survey strains were subcultured on tsab agar, identifications confirmed as a.Faecalis ssp faecalis, and testing included ast-gn70 cards from customer lots (5900755403, 5900678403) and a random lot (5900623403) as well as broth microdilution (bmd) as the reference method for tzp03n formulation on this card.911733 (customer's original d-08 strain): two cards tested gave a resistant mic => 128 and the third card mic = 64 (i).Bmd gave a susceptible mic <= 4.911734 (customer's back-up d-08 strain): all three cards tested gave a resistant mic => 128.Bmd gave a susceptible mic <= 4.911704 (biomerieux internal d-08 strain): on two of the ast-gn70 cards, tzp mic = 64 (i) and on the third card mic <= 4 were obtained.Bmd gave a susceptible mic <= 4.Card and reference method are in agreement for one card while demonstrating an essential agreement error with a minor category error for the remaining two cards.Qs performed a tw search for all complaints against ast-gn70 card lots 5900755403 and 5900678403 returning three and one complaint respectively.A review of these complaints did not indicate a trend for these card lots.This investigation duplicated the customer's inconsistent results.This atypical survey strain will be added to the r&d stock collection.

• Brand Name: VITEK® 2 AST-GN70 TEST KIT
• Common Device Name: VITEK® 2 AST-GN70 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7903831
• Report Number: 1950204-2018-00390
• Device Sequence Number: 11121259
• Product Code: LON
• UDI-Device Identifier: 03573026398477
• UDI-Public: 03573026398477
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/16/2018

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: 10/05/2019
• Device Catalogue Number: 413401
• Device Lot Number: 5900678403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1