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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® MEROPENEM MP 32 WW B30

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BIOMERIEUX, SA ETEST® MEROPENEM MP 32 WW B30 Back to Search Results
Catalog Number 513800
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) reported a false susceptible meropenem result for a klebsiella pneumoniae external quality control sample ((b)(4), specimen (b)(6)) in association with etest® meropenem mp 32 ww b30. The customer repeated the etest three times and reported a susceptible (mic
=
1. 5) result, when the expected was resistant. (mc
=
16). The isolate was also tested on the vitek® ast-n350 card in which meropenem was resistant (mic>
=
16). There was no patient involvement as the event pertained to a quality survey sample. A biomérieux internal investigation will be initiated.
 
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Brand NameETEST® MEROPENEM MP 32 WW B30
Type of DeviceETEST® MEROPENEM MP 32 WW B30
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer Contact
debra broyles
595 anglum road
hazelwood, MO 63042
MDR Report Key8087135
MDR Text Key129331356
Report Number3002769706-2018-00243
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K010363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/20/2019
Device Catalogue Number513800
Device Lot Number1004872950
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
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 Initial

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