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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® IMIPENEM IP 32WW S30

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BIOMERIEUX, SA ETEST® IMIPENEM IP 32WW S30 Back to Search Results
Catalog Number 412374
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 false resistant imipenem results for pseudomonas aeruginosa isolates in association with etest® imipenem ip 32ww s30 (lot 1006022690). In (b)(6) 2018, the customer initially reported false results with vitek® cards, when performing a study for a diploma thesis, on different techniques with ast testing. The customer stated the initial test was with a patient urine sample on a vitek 2 ast-n248 card, and that other tests for the study included the vitek 2 ast-n196, bd phoenix, etest and disk diffusion. The investigation for the vitek cards, concluded that the customer's etest results were false resistant compared to broth microdilution. A biomérieux internal investigation will be initiated.
 
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Brand NameETEST® IMIPENEM IP 32WW S30
Type of DeviceETEST® IMIPENEM IP 32WW S30
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 Key8030587
MDR Text Key127360116
Report Number3002769706-2018-00227
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K913459
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 06/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2022
Device Catalogue Number412374
Device Lot Number1006022690
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 Received05/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2017
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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