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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX SA DAPTOMYCIN DPC 256 WW S30 - 412324

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BIOMÉRIEUX SA DAPTOMYCIN DPC 256 WW S30 - 412324 Back to Search Results
Lot Number 1007847460
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Note: reference 412324 is not registered in the united states. The u. S. Similar device is product reference 412323. A customer in (b)(6) notified biomerieux of obtaining false susceptible daptomycin results in association with the etest® daptomycin cpc 256 ww s30 test strips (ref. 412324, lot 1007847460) when testing sixteen (16) randomly selected enterococcus faecalis isolates from frozen storage. The customer obtained the false susceptible results when performing a comparison study with the vitek® 2 ast-p643 test kit (ref. 418671, lot 7431337103). The customer noted all sixteen (16) isolates obtained susceptible mic results ranging from 0. 19 to 0. 75 when tested with etest® daptomycin cpc 256 ww s30 test strips and resistant mic results when tested on the vitek® 2. The customer submitted four (4) strains to biomérieux for investigation. The isolates were confirmed to be e. Faecalis by vitek® ms. Broth microdilution testing determined all four (4) of the submitted strains were either in agreement or in essential agreement (within two doubling dilutions) with the vitek 2 results. As the false susceptible daptomycin etest® results obtained with lot 1007847460 occurred during a study and not for clinical testing, there is no adverse impact to any patient¿s state of health. Further internal investigation will occur regarding the false susceptible daptomycin etest® results.
 
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Brand NameDAPTOMYCIN DPC 256 WW S30 - 412324
Type of DeviceDAPTOMYCIN DPC 256 WW S30 - 412324
Manufacturer (Section D)
BIOMÉRIEUX SA
3 route de port michaud
la balme 38390
FR 38390
MDR Report Key12249545
MDR Text Key281747057
Report Number9615754-2021-00214
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
PMA/PMN Number
K042392
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2022
Device Lot Number1007847460
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No

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