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 the united states notified biomérieux of false resistant oxacillin results for a patient staphylococcus aureus isolate when testing with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2750973203).The isolate was collected from a nasopharyngeal sample.The initial and first repeat test obtained the same oxacillin results of mic > 4 (resistant).When testing was repeated a week later, the oxacillin result was mic 0.5 (susceptible).Initial: cefoxitin screen = neg (aes modified to pos).Oxacillin = > 4 (resistant).Mrsa pcr = neg.Pbp2a = neg.Repeat 1: cefoxitin screen = neg (aes modified to pos).Oxacillin = > 4 (resistant).Mrsa pcr = neg.Pbp2a = neg.Repeat 2 (1 week later): cefoxitin screen = neg.Oxacillin = (b)(6).Pbp2a = neg.(b)(6) pcr = (b)(6).The customer reported that the discrepant results did not lead to any adverse impact on the patient's health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a false resistant oxacillin result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp75 test kit (ref 415670, lot 2750973203).The isolate was collected from a nasopharyngeal sample.Upon initial testing, a resistant oxacillin mic>=4 was obtained.Repeat testing gave susceptible oxacillin mics of 0.5 and <=0.25.The customer was unable to ship the strain for investigation.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference methods.The customer submitted raw data to be reviewed.Review of customer data showed that the replicate with oxacillin mic of >=4 had slightly atypical growth.The two replicates with mics of <=0.25, 0.5, respectively, did not demonstrate the slightly atypical growth.Ast-gp75 lot #2750973203 met final qc release criteria.This 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: 8959930
• Report Number: 1950204-2019-00258
• Device Sequence Number: 2860146
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/21/2019

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: 07/26/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2750973203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1