MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-ST01 TEST KIT; VITEK® 2 AST-ST01 CARD

Catalog Number	410028
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 biomerieux of false resistant penicillin results when performing susceptibility testing with vitek 2 ast-st01 test kit (ref (b)(4).Vitek 2 obtained a result of resistant (mic 0.12) for streptococcus pneumoniae.Etest was performed to confirm the result, and it provided a result of susceptible (mic 0.023).There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.The customer stated there was a delay in reporting patient results of greater than 24 hours.A biomerieux internal investigation has been initiated.
Additional Manufacturer Narrative
A customer in (b)(6) had notified biomérieux of a false resistant penicillin result when performing susceptibility testing with vitek® 2 ast-st01 test kit (ref 410028), lot 5400472203.Vitek® 2 obtained a result of resistant (mic 0.12) for streptococcus pneumoniae.Etest® was performed to confirm the result, and it provided a result of susceptible (mic 0.023).An internal biomérieux investigation was performed.The customer's strain was submitted, but was no longer viable for investigation.Isolate submittal is required in order to confirm a vitek 2 discrepancy compared to the reference method.Vitek 2 raw card data are required in order to assess organism growth in the card.Vitek 2 ast-st01 lot # 5400472203 met final qc release criteria.These lots passed qc performance testing.

• Brand Name: VITEK® 2 AST-ST01 TEST KIT
• Common Device Name: VITEK® 2 AST-ST01 CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7095391
• Report Number: 1950204-2017-00433
• Device Sequence Number: 1378842
• Product Code: LON
• UDI-Device Identifier: 03573026345334
• UDI-Public: 03573026345334
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K11200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 03/13/2019
• Device Catalogue Number: 410028
• Device Lot Number: 5400472203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1