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	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported a misidentification of staphylococcus lugdunensis as leuconostoc mesenteroides for two patient isolates with the vitek® 2 gp id test kit.On (b)(6) 2018, the gp card identified leuconostoc mesenteroides and the isolates were confirmed as staphylococcus lugdunensis by maldi-tof.The customer reported that the vitek result was not reported to a physician and patient care was not impacted.The local field application specialist (fas) went to the site and retested the isolates and the identification was staphylococcus lentus (99%).The fas then tested a fresh isolate at a different customer site and the identification was staphylococcus lugdonensis (99%).The customer performed repeat testing on the two isolates on their three vitek instruments.Isolate (b)(4) was identified as staphylococcus lentus on all three instruments.Isolate (b)(4) had one identification as staphylococcus lentus and two as staphylococcus lugdonensis.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a misidentification of staphylococcus lugdunensis as leuconostoc mesenteroides for two patient isolates with the vitek® 2 gp id test kit.The customer submitted the two gram positive isolates for vitek 2 evaluation.Both isolates were subcultured and tested on the customer gp id lots and a random gp lot.Vitek ms was also performed.For both isolates, an excellent id of s.Lugdunensis was obtained on all cards tested.Vitek ms also identified both isolates as s.Lugdunensis, with a 99.9% confidence value.A comparison of reaction results for customer cards giving an identification of l.Mesenteroides against expected reaction results for s.Lugdunensis revealed eight (8) atypical negative results (adh1, pyra, dmal, ilatk, dmne, mbdg, o129r, sac) that led to the incorrect call.A comparison of reaction results for customer cards giving an identification of s.Lentus against expected reaction results for s.Lugdunensis revealed one (1) atypical positive result (amy) that led to the incorrect call.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media, user set up error, or an atypical strain.A complaint search against gp card lots 2420735203 and 2420668403 did not indicate any issues for these lots.The vitek 2 gp id cards performed as expected and no further action is necessary.

• 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: 8017119
• Report Number: 1950204-2018-00450
• Device Sequence Number: 1303096
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/15/2019

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: 12/01/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420735203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1