MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT

Model Number 410895

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of a misidentification of granulicatella adiacens as staphylococcus capitis in association with vitek® ms instrument (ref.410895, serial number (b)(4).Investigation: fine tuning: status good at the time of acquisition.Spot preparation quality: the customer¿s spot preparation quality seems to be good - sample ¿all peaks¿ values are homogeneous.Knowledge base (kb) review: the expected identification is unknown because no reference method was used to confirm the expected identification.Sample data analysis: analysis of mzml sample files show that number of all peaks are low during the issue (31 for each spectra) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (minimum 30 peaks).In addition, the misidentification was obtained with a low identification score (-0.39) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).Reprocessing the customer data with saramis kb v4.17 (ruo), spectra which gave misidentification results as staphylococcus capitis led to "no identification".For both customer sample spectra, there are presence of peaks near 7.5 kda and near 15 kda (double-charged peak).This observation suggests these spectra are hemoglobin peaks.The hemoglobin peaks are prominent and prevent the expression of the other proteins.However, these peaks of hemoglobin are not present in the ecal mzml files.Conclusion based on these findings (low number of peaks and presence of hemoglobin peaks), a non-optimal sample preparation quality is suspected, probably linked to agar picking for the deposit (strain with rough colony or difficult to collect).Local customer service provided additional training materials to the customer to help improve the spot preparation technique and discussed the importance of following the correct protocol (bacteria vs yeast) to obtain correct identifications.Customer service also provided information regarding vitek® pickme¿ (ref 423551/ 423546) to further assist with sample spot preparation.

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of granulicatella adiacens as staphylococcus capitis in association with vitek® ms instrument (ref.410895, serial number (b)(4).The sample was incubated aerobically on tsa 5% sheep blood agar for 18 hours.Summary of results: vitek® ms system provided an organism id to staphylococcus capitis 97.5%.Method of confirmation vitek 2: granulicatella adiacens colony morphology = alpha hemolytic in the bap (blood agar plate).Additional tests: gram stain, catalase = results not provided.Granulicatella adiacens identification for this sample was reported to the physician.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13054549
• MDR Text Key: 291512433
• Report Number: 9615754-2021-00298
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181412
• 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
• Report Date: 12/21/2021

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
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/21/2021
• 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: A
• Patient Sequence Number: 1