MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GP ID TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Misdiagnosis (2159)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in (b)(6) notified biomérieux of a misidentification of staphylococcus haemolyticus as staphylococcus aureus in association with the vitek® 2 gram positive (gp) identification (id) test kit (ref.21342, lot 2421088403).The susceptibility testing was performed using the organism id of staphylococcus aureus, and the strain was further identified as (b)(6).The patient was isolated and treated against staphylococcus aureus (vancomycin + amikacin).Vitek 2 gp id = staphylococcus aureus.National laboratory for study (reference lab) = staphylococcus haemolyticus (testing method not disclosed by the customer).Following receipt of the reference lab result, retesting via vitek® ms and vitek® 2 gp id obtained organism identifications to staphylococcus haemolyticus.The customer stated there was a "delay of 48 hours".The customer also stated "the patient was treated incorrectly" [i.E.For staphylococcus aureus (b)(6) rather than staphylococcus haemolyticus].Though multiple attempts have been made by biomérieux to obtain information regarding the patients health, there have been no statement(s) from the laboratory or the treating physician regarding treatment effectiveness, additional therapy, changes to therapy, adverse patient impact, or the patient outcome.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in (b)(6) regarding a misidentification of staphylococcus haemolyticus as staphylococcus aureus in association with the vitek® 2 gram positive (gp) identification (id) test kit (ref.21342, lot 2421088403).Reference lab testing confirmed the identification as staph.Haemolyticus.Two lab reports with the misidentification of s.Aureus were received.Both were tested on vitek® 2 gp lot 2421088403 and 8.01 software.A review of the both lab reports indicated four atypical positive reactions (bgal, polyb , novo, mbdg) for a call of staph.Haemolyticus according to the gp knowledge base.Atypical positive reactions can indicate contamination, mixed culture, other user set up errors or an atypical strain.The strain was not saved for investigation.Since the strain could not be submitted for investigational purposes, no additional investigation could be completed.Vitek® 2 gp id cards, lot 2421088403, met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GP ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9156792
• Report Number: 1950204-2019-00295
• Device Sequence Number: 19508227
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: C1 EXEMPT
• 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): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: 21342
• Device Lot Number: 2421088403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other