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 biomérieux of false resistance for ceftriaxone when performing susceptibility testing with vitek® 2 ast-st01 test kit (ref 410028).Vitek® 2 obtained a result of resistant for a staphylococcus constellatus strain isolated from a cerebral abscess from a (b)(6) patient.Etest® was performed to confirm the result, and it provided a result of susceptible (mic 0.19).The customer stated that there were no wrong results reported to a physician.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 biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification by a customer in (b)(6) of false resistance for ceftriaxone result when performing susceptibility testing with vitek® 2 ast-st01 test kit (ref 410028).Vitek® 2 had obtained a result of resistant for a staphylococcus constellatus strain isolated from a cerebral abscess from a (b)(6) patient.Etest® was performed to confirm the result, and it provided a result of susceptible (mic 0.19).Biomérieux investigation was conducted.However, the customer did not comply with biomérieux's request for strain submittal or test raw data.Submittal of the strain is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 card raw data are required to assess organism growth in the card.Vitek® 2 ast-st01 lot # 5400432103 met final qc release criteria.This lot passed initial qc performance testing.No ncmrs were written against this lot.Ncmrs were reviewed for the last 13 months (20jan2017-20feb2018).No ncmrs were written for the ast-st01 card.Without the patient strain or test raw data, no further investigation is possible.

• 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: 7048335
• Report Number: 1950204-2017-00410
• Device Sequence Number: 19150440
• Product Code: LON
• UDI-Device Identifier: 03573026345334
• UDI-Public: 03573026345334
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N50510: S135
• 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): 04/03/2018

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: 02/01/2019
• Device Catalogue Number: 410028
• Device Lot Number: 5400432103
• 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: 10/26/2017
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR