MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP67 TEST KIT; VITEK® 2 AST-GP67 TEST KIT 20 CARDS - 22226

Catalog Number	22226
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
Event or Problem Description
A customer in (b)(6) notified biomérieux of false positive (resistant) cefoxitin screen (oxsf) results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321166403).Repeat analysis with the vitek® 2 ast-gp67 test kit obtained a negative (susceptible) oxsf result.Oxascreen testing was performed as an alternative method and obtained susceptible results.Initial vitek® 2: oxsf = positive (resistant).Repeat vitek® 2: oxsf = negative (susceptible).Oxascreen = susceptible.The customer indicated that there was a delay of >24 hours in reporting results, but there is no indication or report from the customer that the initial false positive cefoxitin screen result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint for false positive (resistant) cefoxitin screen (oxsf) results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321166403).The strain from this particular patient was not available for investigational testing.Another strain from the same customer, that also produced false positive cefoxitin screen results in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321144103) was submitted for investigational testing.The submitted strain's identification was verified to be staphylococcus aureus and investigational testing included testing with the vitek® 2 ast-gp67 test kit from the customer's lots (1321144103 & 1321166403) and a random lot (1321211203) in duplicate as well as agar dilution (ad) and cefoxitin disk diffusion as the reference methods for ox101n and oxsf01n formulations found on this card.Alere pbp2 was also performed.Oxacillin (ox) mic¿s = 0.25 mg/l were obtained for five of the six cards tested with the remaining card ox mic = 0.5 mg/l.The ox agar dilution mic = 0.25 mg/l.The oxsf all tested negative for all cards while the cefoxitin disc diffusion was susceptible at 24 mm.Pbp2 was also negative.The customer's false positive cefoxitin screen results were not reproduced internally.The vitek® 2 ast-gp67 test kit cards are in agreement or essential agreement with the reference methods for oxacillin and cefoxitin screen tests and the cards are performing as expected.Ast-gp67 lots 1321144103 and 1321166403 met final qc release criteria.These lots passed qc performance testing.See h10 for addtl mfg narrative.

• Brand Name: VITEK® 2 AST-GP67 TEST KIT
• Common Device Name: VITEK® 2 AST-GP67 TEST KIT 20 CARDS - 22226
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9756091
• Report Number: 1950204-2020-00021
• Device Sequence Number: 16787802
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• 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): 03/27/2020

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: 02/04/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321166403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1