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

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in germany notified biomérieux of obtaining a misidentification of staphylococcus haemolyticus as leucononstoc mesenteroides ssp.Cremoris in association with the vitek® 2 gp id test kit (ref 21342, lot 2421450403) and their vitek® 2 compact 30 [u] (ref 27530u, serial vk2c18637).Troubleshooting by local customer service (lcs) identified that there was no indication of off-label use or user error with respect to culturing the organism prior to analyzing them with the gp id test kit.Due to the type of issue being observed by the customer, lcs suspected the customer's instrument may be the source of the problem and lcs identified that the customer's instrument was overdue for preventive maintenance (pm).The previous pm was completed in may 2019.It is recommended that this pm is performed at least annually.The customer was instructed by lcs to use alternate test methods for identification and ast testing until a pm could be completed.A pm was performed on 20oct2020 by a field service engineer (fse) and then the isolate was retested.The customer reported that there were no issues with the results obtained after the pm was completed.Isolate 10054568 initial test = leuconostoc mesenteroides ssp.Cremoris repeat test (after pm) = staphylococcus haemolyticus the customer reported that the results obtained prior to the pm completion were not taken into account for patient treatment.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding multiple misidentifications in association with the vitek® 2 gp id test kit (ref (b)(4), lot 2421450403) and their vitek® 2 compact 30 [u] (ref (b)(4), serial (b)(6)).The customer encountered misidentifications of four (4) patient strains and a low reactivity pattern for an additional two (2) strains when using vitek® 2 gp id cards from lot 2421450403.Local customer service (lcs) suspected an instrument issue or dirty optics.It was noted that the customer was overdue for preventative maintenance (pm) and the field service engineer (fse) went onsite to perform the pm.The customer¿s optics were found to be dirty prior to the pm.After the pm, all six (6) isolates gave the expected identifications upon repeat testing when using the same lot number of gp id cards (2421450403).As the expected identifications were obtained after preventative maintenance was performed, the isolates were not requested for investigation.With the exception of isolate 10054567-2, the remaining five (5) isolates all had multiple unexpected negative biochemical reactions in comparison to their expected identifications per the gp id knowledge base.For isolate 10054567-2, the initial lab report showing an identification of e.Faecium had eight (8) atypical positive reactions, and three (3) atypical negative reactions for an intended staphylococcus hominis identification per the gp id knowledge base.An increased number of atypical reactions can indicate an instrument issue or other user set up error.A complaint history review was completed for this issue during the last 13 month time frame with no implication of a trend.Gp id lot 2421450403 met final qc release criteria and passed qc performance testing.

Manufacturer Narrative

In alignment with the most recent fda guidance, ¿medical device reporting for manufacturers, issued november 8, 2016¿, biomérieux is submitting this notification to fda to inform the agency of the decision to cease reporting specific vitek® 2 malfunction events after two years of no occurrences associated with death or serious injury.For the specific combinations of product and malfunction type, customer complaints were reviewed over a two year period starting from the date of awareness of the most recent event that was classified as a serious injury or death.For the following malfunction types, this review identified no additional occurrences of being associated with death or serious injury for two years.Product code: lql.Reference: 21342.Malfunction: misidentification of staphylococcus haemolyticus.Final mdr submitted: 1950204-2020-00201.We wish to inform you that with the completion of our mdr data analysis, we have updated our mdr criteria for vitek 2 product code lql, and will no longer report this malfunction event because it has not caused or contributed to a death or serious injury in the past two years.Moving forward, if biomérieux becomes aware of a death or serious injury event for the product code lql, we will report that event to the fda per the fda mdr guidance, and will update our mdr criteria to require reporting the specific associated malfunction as required by this guidance.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 angum road; hazelwood, NC 63042
• MDR Report Key: 10792457
• MDR Text Key: 214799497
• Report Number: 1950204-2020-00201
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: 21342
• Device Lot Number: 2421450403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1