MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS MYCOBACTERIUM/NOCARDIA KIT; VITEK MS MYCOB/NOCARDIA KIT

Catalog Number	415659
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 the united states notified biomérieux of a misidentification of mycobacterium tuberculosis complex (mtbc) as mycobacterium celatum when testing a patient isolate with the vitek® ms mycobacterium/nocardia kit (ref 415659, lot 1007187830).The strain was sent to a reference laboratory and was identified as mtbc by genetic sequencing.The customer stated that the misidentification caused a delay in reporting results to the physician, but no incorrect results were reported and no inappropriate treatment was provided.Although treatment was delayed while the identification was being verified, there is no report or indication from the laboratory that the delay in treatment 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 completed in response to a customer complaint for a misidentification of mycobacterium tuberculosis complex (mtbc) as mycobacterium celatum when testing a patient isolate with the vitek® ms mycobacterium/nocardia kit (ref 415659, lot 1007187830).The investigation did not require strain submission for completion.The customer's data was provided for analysis during the investigation.Review of the data indicated that the customer's spot preparation for calibrator spots was non-optimal, however the samples being tested were liquid samples that would be homogenous.Review of the two sample spots indicated that there was a lack of biomass in the samples.Spot 1 - no peaks with a result of no identification (nothing in the supernatant put on the spot) spot 2 - only 32 peaks (12 bad peaks, 5 good peaks); number of peaks was sufficient for a good genus identification, but not enough for a good species level identification.The suspected causes for the misidentification are a lack of biomass in the sample and operator error when following the protocol.Local customer service (lcs) was instructed to provide the customer with additional training materials to improve performance of the mycobacteria-liquid sample preparation protocol.A complaint trend analysis from january 2016 to present concluded that no other complaints have been recorded for a similar identification issue.

• Brand Name: VITEK® MS MYCOBACTERIUM/NOCARDIA KIT
• Common Device Name: VITEK MS MYCOB/NOCARDIA KIT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9187136
• Report Number: 9615754-2019-00103
• Device Sequence Number: 2402350
• Product Code: PEX
• UDI-Device Identifier: 03573026436971
• UDI-Public: 03573026436971
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 02/20/2020
• Device Catalogue Number: 415659
• Device Lot Number: 1007187830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1