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U.S. Department of Health and Human Services

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

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BIOMÉRIEUX SA ETEST DAPTOMYCIN DPC 256 WW S30 ETEST® DAPTOMYCIN DPC 256 WW S30 Back to Search Results
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
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4 mg/l (resistant); customer repeat vitek 2: dap mic
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4 mg/l (resistant); customer etest daptomycin: mic
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1. 5 mg/l (susceptible); investigation bmd: dap mic
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2 mg/l (resistant). Patient 2: initial vitek 2: dap mic
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2 mg/l (resistant); repeat vitek 2: dap mic
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4 mg/l (resistant); etest daptomycin: mic
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0. 75 mg/l (susceptible); investigation bmd: dap mic
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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).
 
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Brand NameETEST DAPTOMYCIN DPC 256 WW S30
Type of DeviceETEST® 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 Key10766465
MDR Text Key241364592
Report Number9615754-2020-00175
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042392
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Catalogue Number412324
Device Lot Number1007622910
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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