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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in the 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 1007645760). 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 Key9885898
MDR Text Key208192634
Report Number9615754-2020-00052
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 Date10/10/2022
Device Catalogue Number502658
Device Lot Number1007645760
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 Manufactured10/11/2019
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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