MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of micrococcus luteus/lylae as arcanobacterium haemolyticum in association with the vitek ms system.The customer stated there was no impact on patient reporting; there was a minor delay since they had to repeat testing.The log files from the vitek ms were submitted for evaluation.The results indicated that fine-tuning, spot preparation, and/or culture conditions may have caused the misidentification.When the misidentification occurred, "all peaks" criteria and "good peaks" criteria were below the threshold.The local field service engineer visited the customer site and performed a fine-tuning procedure.Subsequent specimen testing by the customer indicates the issue now seems to be resolved.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.Culture submittal was requested by biomerieux for internal investigation.Biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of micrococcus luteus/lylae as arcanobacterium haemolyticum in association with the vitek® ms system.An internal biomérieux investigation was performed.Summary of the data provided and analyzed: 2 sample mzml files, 28 ecal mzml files.Vitek® ms result: regarding the samples mzml data files: 29sep2016 (mb6463-i2): single choice to listeria grayi , 30sep2016 (mb6463rpt-j2): single choice to arcanobacterium haemolyticum.Other identification method: vitek® 2: low discrimination confidence to micrococcus luteus/lylae.Expected identification: unknown.Orientation tests: gram staining - coryne form, gram positive organism.Arcanobacterium haemolyticum is catalase negative but the culture yielded a catalase positive reaction with no hemolysis.Culture conditions: specimen = blood culture.Issue date : 29 & 30sep2016 (regarding the samples mzml data files).Last fine-tuning date: 30sept2016.Note: the organism was a coryneform bacterium, but micrococcus is a gram positive cocci organism.Customer decided that the isolate could have been a contaminant and it was discarded.Unfortunately, it is unavailable for submittal.The repeat gram showed that it was a gram positive cocci and the colonies on culture looked like yellow (like micrococcus color characteristic).Immediate action: vitek® 2 was performed.New gram staining was performed.Fine tuning was performed at the customer site on 06aug2016 after the misidentification occurred.Conclusion on the system: system was not operational during customer tests.Conclusion on the identification: based on the analysis of the information provided by the customer, the most probable identification is micrococcus.However, this hypothesis could not be confirmed as the sample was not available for re-test after fine tuning and for the investigation.Suspected root cause of the issue: non-optimal fine tuning.Corrected data: updated device manufacturing site address.Removed check on repair.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, MO 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6081362
• MDR Text Key: 59356743
• Report Number: 3002769706-2016-00463
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

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
• Device Operator: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1