MAUDE Adverse Event Report: BIOMÉRIEUX, INC. 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
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in (b)(6) notified biomérieux of false resistant oxacillin results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321144103).Repeat analysis with the vitek® 2 ast-gp67 test kit obtained a susceptible result.Initial vitek® 2: oxacillin mic >= 4 mg/l (resistant).Repeat vitek® 2: oxacillin mic = 0.5 mg/l (susceptible).The customer confirmed that there was a delay of > 24 hours in reporting results due to the repeat testing.There is no indication or report from the laboratory that the false resistant result or delay led to any adverse event related to the patient's state of health.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint for false resistant oxacillin results for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-gp67 test kit (ref 22226, lot 1321144103).The customer¿s isolate was received and the identification of the isolate was confirmed as staphylococcus aureus via vitek® ms (99.9% confidence).Investigational testing of the isolate included vitek® 2 cards from the customer¿s lot (1321144103) and a random lot (1321316203), both in duplicate.In addition, oxacillin agar dilution, cefoxitin disk diffusion and alere pbp2a testing were also performed.For all four cards tested, an oxacillin mic = 0.5 mg/l (susceptible) was obtained.Oxacillin agar dilution (mic = 1 mg/l) and cefoxitin disc diffusion (24 mm) were both susceptible, while alere pbp2a was negative.The customer¿s false resistance was not duplicated.The vitek® 2 ast-gp67 test kit cards are in essential and categorical agreement with the reference method and are performing as intended.Ast-gp67 lot 1321144103 met final qc release criteria.The lot passed qc performance testing.See h10 for addtl mfg narrative.

• Brand Name: AST-GP67 TEST KIT 20 CARDS - 22226
• Common Device Name: AST-GP67 TEST KIT 20 CARDS - 22226
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9629864
• Report Number: 1950204-2020-00011
• Device Sequence Number: 11459037
• Product Code: LON
• UDI-Device Identifier: 03573026242060
• UDI-Public: 03573026242060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N50510: S117
• 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): 03/26/2020

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: 01/13/2021
• Device Catalogue Number: 22226
• Device Lot Number: 1321144103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1