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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in (b)(6) contacted biomérieux to report false resistant ceftriaxone (mic = 1) for streptococcus constellatus in association with the vitek® 2 ast-st01 test kit.Etest® obtains a result of mic = 0.25 or 0.19 (susceptible).The customer stated that only the etest® result was reported to the physician.The discrepant vitek® 2 ast-st01 result had no impact on patient treatment and no adverse impact on the patient's state of health.The customer indicated a delay of >24 hours to report the etest® result to the physician.Biomérieux has requested isolate submittal for internal investigation.An internal investigation has been initiated.
Additional Manufacturer Narrative
A customer in (b)(6) contacted biomérieux to report false resistant ceftriaxone (mic = 1) for streptococcus constellatus in association with the vitek® 2 ast-st01 test kit.An investigation was performed.A review of quality records confirmed that vitek® 2 ast-st01 lot 5400332203 passed initial qc performance testing and met final qc release criteria.The customer submitted the strain and the ast-st01 cards for evaluation.However, the strain was contaminated and the customer no longer had the isolate.Without the isolate, confirmation of the discrepancy compared to reference method cannot be confirmed.

• 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: 6807101
• Report Number: 1950204-2017-00274
• Device Sequence Number: 130212
• 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): 10/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2018
• Device Catalogue Number: 410028
• Device Lot Number: 5400332203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1