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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 US F100 BENZYLPENICIL PG 32 US F100 - 502658

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BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 US F100 BENZYLPENICIL PG 32 US F100 - 502658 Back to Search Results
Catalog Number 502658
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in united states notified biomérieux of out-of-range high benzylpenicillin results for enterococcus faecalis atcc® 29212¿ when performing internal quality control testing with the etest® benzylpenicil pg 32 us f100 (ref 502658, lot 1007341070). The customer obtained a mic of 32 mg/l (resistant) and the expected range for enterococcus faecalis atcc® 29212¿ is 1 - 4 mg/l (susceptible). As the customer was performing internal qc testing, there is no patient involved. A biomérieux internal investigation will be initiated.
 
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Brand NameETEST® BENZYLPENICIL PG 32 US F100
Type of DeviceBENZYLPENICIL PG 32 US F100 - 502658
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme
FR
Manufacturer (Section G)
BIOMERIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key9886020
MDR Text Key225600326
Report Number9615754-2020-00053
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026252465
UDI-Public03573026252465
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2022
Device Catalogue Number502658
Device Lot Number1007341070
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 Received05/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2019
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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