MAUDE Adverse Event Report: BIOMÉRIEUX, INC. AST-GP75 TEST KIT 20 CARDS - 415670

Catalog Number	415670
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in the united states notified biomérieux of a false resistant oxacillin (ox) result (mic>=4) for a patient staphylococcus aureus strain (source=blood) in association with the vitek® 2 ast-gp75 test kit.Repeat testing obtained the same ox resistant result.The customer sent the isolate to a reference laboratory for confirmatory testing.The reference lab obtained a result of ox susceptible (mic<=0.25) via agar dilution (ad), and tested the isolate meca negative via verigene.The customer performed vitek 2 testing from other body sites with the same ox results.The customer stated the patient is currently being treated with vancomycin.There is no indication or report from the laboratory or treating physician that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A us customer reported a false resistant oxacillin (ox) result for a patient¿s staphylococcus aureus strain isolated from a blood culture using vitek® 2 ast-gp75 lot 2751197203, with initial and repeat testing.The strain was negative for meca by verigene as well as oxacillin susceptible (mic <=0.25) by agar dilution performed by a reference lab.The strain was submitted for investigation.The submitted strain was subcultured to tsab agar and identification confirmed as staphylococcus aureus.Testing included ast-gp75 cards from the customer¿s lot (2751197203) and a random lot (2751124403) in duplicate, as well as agar dilution (ad) and cefoxitin disc diffusion as the reference methods for ox101n and oxsf01n formulations found on this card.Pbp2 was also tested.All four (4) ast-gp75 cards resulted in ox mics = 4 (r).Ox ad mic = 0.5 (s).The cefoxitin screen test (oxsf) was negative for all four cards, with aes modifications to positive due to the resistant oxacillin mics.Cefoxitin disc diffusion was susceptible (23 mm) and pbp2 was negative for meca.R&d review of the internal testing data showed less than robust growth in the oxacillin pc wells for this strain.Ast-gp75, lot 2751197203 met final qc release criteria.The lot passed qc performance testing.No ncmrs or ncs were written against this lot.Ncmrs and ncs were reviewed for the last 13 months (06dec2018 to 06jan2020).No ncmrs or ncs were written for the ast-gp75 card for performance issues.Global customer service (gcs) performed a search for all complaints against ast-gp75 card lot 2751197203.A review of the four returned complaints did not indicate a trend for this card lot.The investigation concluded the patient strain to be atypical.The adverse event is due to the patient condition.The strain will be added to the r&d stock collection.

• Brand Name: AST-GP75 TEST KIT 20 CARDS - 415670
• Common Device Name: AST-GP75 TEST KIT 20 CARDS - 415670
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9484160
• Report Number: 1950204-2019-00326
• Device Sequence Number: 235144
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N50510: S117
• 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): 02/06/2020

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: 03/07/2021
• Device Catalogue Number: 415670
• Device Lot Number: 2751197203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1