MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN69 TEST KIT; 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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a false resistant result associated with vitek® 2 ast-gn69 test kit (reference (b)(4)).The customer reported obtaining an incorrect cap survey result where piperacillin/tazobactam was incorrect.The expected result was sensitive.The original result was submitted as resistant >=128 (r).The customer pulled the specimen and performed repeat testing on vitek® 2 and microscan.Vitek® 2 yielded the same result of >=128 (r) and microscan had a result of <=16 (s).The customer mentioned that this portion of the survey is ungraded.There is no patient involvement due to being a cap survey.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
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-gn69 card.The alcaligenes faecalis ssp.Faecalis strain resulted in resistant mics >/= 128 for piperacillin/tazobactam (tzp).The expected result was susceptible.The strain was submitted for investigation.The customer's submitted strain and the biomerieux cap d-08 survey strains were subcultured on tsab agar, identifications confirmed as a.Faecalis ssp faecalis, and testing included ast-gn69 cards from customer lots (5890758403, 5890708203) and a random lot (5890711103) as well as broth microdilution (bmd) as the reference method for the tzp formulation on this card (tzp03n).911703 (customer's d-08 strain): all three cards tested gave a resistant mic >/= 128.Bmd gave a susceptible mic /= 128 were obtained.Bmd gave a susceptible mic

• 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: 7901319
• Report Number: 1950204-2018-00386
• Device Sequence Number: 148653
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/14/2018

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: 12/24/2019
• Device Catalogue Number: 413400
• Device Lot Number: 5890758403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1