MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST CARD

Catalog Number 22226

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux false negative cefoxitin screen results for two (2) samples from one patient (tracheal aspiration and blood culture) in association with the vitek® 2 ast-gp67 test kit.For the first sample (tracheal aspirate), two staphylococcus isolates were set up but not repeated on the vitek®.The second sample (blood culture), with two isolates set up, was repeated several times on the vitek® with the same results.The customer also tested the four isolates on an alternate system (phoenix) in which the 2 blood cultures and 1 trach aspirate isolate were (b)(6), and the other trach isolate was (b)(6).The staphylococcus aureus isolates were confirmed using filmarray® and the results were (b)(6).Other molecular testing confirmed the isolates to be pbp2a positive and (b)(6).The results from the vitek® 2 or alternate system were not reported to a physician, as it is customer procedure to confirm with molecular testing.The (b)(6) result was reported to the physician.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The test reports and isolates were requested from the customer.

Manufacturer Narrative

A customer from the united states reported to biomérieux false negative cefoxitin screen results for two (2) samples from one patient (tracheal aspiration and blood culture) in association with the vitek® 2 ast-gp67 test kit.An internal biomérieux investigation was performed.Four (4) submitted isolates were subcultured, identifications confirmed, and vitek® 2 ast-gp67 testing included cards from the customer's lot and a random lot, in duplicate.Additional testing included agar dilution (ad) reference method for ox101n formulation, cefoxitin disc diffusion as the reference method for oxfs and pbp2a.The 911296 (w44346-1r): all four (4) vitek® 2 ast-gp67 cards tested resulted in mics = 0.5 and negative oxfs.Ad mic = 1.0 so vitek® 2 cards were in essential agreement with the reference method for oxacillin.Cefoxitin disc (18 mm) was resistant and pbp2a was positive, confirming the false negative oxfs.The 911297 (w44346-2 r): all four (4) vitek® 2 ast-gp67 cards tested resulted in mics

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Type of Device: VITEK® 2 AST-GP67 TEST CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6349544
• MDR Text Key: 68224543
• Report Number: 1950204-2017-00059
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2018
• Device Catalogue Number: 22226
• Device Lot Number: 1320159103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1