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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST FOSFOMYCIN FM 1024 WW B30 FOSFOMYCIN FM 1024 WW B30 - 529100

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BIOMERIEUX SA ETEST FOSFOMYCIN FM 1024 WW B30 FOSFOMYCIN FM 1024 WW B30 - 529100 Back to Search Results
Catalog Number 529100
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomrieux of a false susceptible result for klebsiella pneumoniae when testing a neqas survey sample with the etest fosfomycin fm 1024 ww b30 (ref 529100, lot 1006972040). As this was a neqas survey sample, there is no patient involved. Repeat analysis with etest also obtained a susceptible result. Initial: fosfomycin mic
=
24 mg/l (susceptible) repeat: fosfomycin mic
=
12 mg/l (susceptible) expected: fosfomycin
=
resistant ref 529100 is not marketed or sold in the united states. The us version of the product is ref 529140 (k981136). A biomrieux internal investigation will be initiated.
 
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Brand NameETEST FOSFOMYCIN FM 1024 WW B30
Type of DeviceFOSFOMYCIN FM 1024 WW B30 - 529100
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key9967419
MDR Text Key240339515
Report Number9615754-2020-00068
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K981136
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,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2020
Device Catalogue Number529100
Device Lot Number1006972040
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 Received06/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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