MAUDE Adverse Event Report: BIOMÉRIEUX SA ETEST DAPTOMYCIN DPC 256 WW S30; ETEST® DAPTOMYCIN DPC 256 WW S30

Catalog Number 412324

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

An internal complaint was initiated after the conclusion of an investigation related to a customer complaint of false resistant daptomycin results for two staphylococcus aureus isolates in association with the vitek® 2 ast-p654 (ref 421912).The customer had performed etest® daptomycin testing as an alternative method and obtained susceptible results.The internal investigation ((b)(4)) concluded that the vitek 2 results were in agreement with the reference method and the customer had obtained false susceptible results in association with the etest® daptomycin dpc 256 ww s30 (ref 412324, lot 1007622910).The customer's strains were submitted for investigational testing.Broth microdilution (bmd) was performed on both strains as the reference method and obtained resistant results for both strains.The vitek 2 results were found to be in agreement with the bmd results, while the etest results were not.Patient 1: customer initial vitek 2: dap mic = 4 mg/l (resistant); customer repeat vitek 2: dap mic = 4 mg/l (resistant); customer etest daptomycin: mic = 1.5 mg/l (susceptible); investigation bmd: dap mic = 2 mg/l (resistant).Patient 2: initial vitek 2: dap mic = 2 mg/l (resistant); repeat vitek 2: dap mic = 4 mg/l (resistant); etest daptomycin: mic = 0.75 mg/l (susceptible); investigation bmd: dap mic = 2 mg/l (resistant).There is no indication or report from the customer that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated for the etest discrepancy.Ref 412324 is not marketed or sold in the united states.The us version of the product is ref 412323 (k042392).

• Brand Name: ETEST DAPTOMYCIN DPC 256 WW S30
• Type of Device: ETEST® DAPTOMYCIN DPC 256 WW S30
• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10766465
• MDR Text Key: 241364592
• Report Number: 9615754-2020-00175
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 412324
• Device Lot Number: 1007622910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1