MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP75 TEST KIT; AST-GP75 TEST KIT 20 CARDS

Catalog Number	415670
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of receiving false positive cefoxitin screen results for staphylococcus aureus for two isolates from two different patients when testing with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751103203).Cefoxitin (fox) disk diffusion testing was performed as an alternative method and obtained susceptible results for both isolates.The customer reported that the false positive cefoxitin screen results did not lead to any adverse event related to either patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of receiving false positive cefoxitin screen results for staphylococcus aureus for two isolates from two different patients when testing with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2751103203).The customer did not save the strains and no investigational testing could be performed with the strains.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.Global customer service (gcs) reviewed complaints coded against ast-gp75, lot 2751103203 and the review did not indicate a trend for this card lot.Ast-gp75, lot 2751103203 met final qc release criteria.The lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GP75 TEST KIT
• Common Device Name: AST-GP75 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9266475
• Report Number: 1950204-2019-00311
• Device Sequence Number: 1850365
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 12/03/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2751103203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1