• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® BENZYLPENICILLIN PG 32 WW F100

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX SA ETEST® BENZYLPENICILLIN PG 32 WW F100 Back to Search Results
Catalog Number 502618
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 from (b)(6) notified biomérieux of potential discrepant results for benzylpenicillin when testing 14 streptococcus pneumoniae strains from patient isolates on etest® benzylpenicillin pg 32 (ref. 502618), lot. 1006836110, when compared to the reference laboratory results. It should be noted that the customer used homemade media for testing with etest®. The reference laboratory used prepared plates for bmd. Based on the information provided by the customer, the comparison of results obtained with the impacted lot of etest® to the reference mic results (obtained with bmd) are summarized as follows: for eight (8) strains, mic values obtained with the impacted lot of etest® are in agreement with the reference mic results. For three (3) strains, there are discrepant results between etest® and the bmd method but without any error of category (intermediate). For one (1) strain, the mic value with etest® is in agreement with the reference mic result, but on the high critical concentration that led to a minor error of category (intermediate instead of resistant). For two (2) strains, there are discrepant results between etest® and the bmd method with a minor error of category (intermediate instead of resistant) due to the fact that the mic values for those strains are on the high breakpoint. In summary, 11 of the 14 strains had no change in the susceptibility category. Three (3) of the 14 strains category call was intermediate instead of resistant. The customer did not report any known incorrect treatment or patient injury due to these discrepant results. A biomérieux internal investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETEST® BENZYLPENICILLIN PG 32 WW F100
Type of DeviceETEST® BENZYLPENICILLIN
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme les grottes isere 383,
FR
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, 38390
FR 38390
Manufacturer Contact
jennifer armstrong
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key8880347
MDR Text Key218538146
Report Number9615754-2019-00059
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K981135
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 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2021
Device Catalogue Number502618
Device Lot Number1006836110
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 Received10/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-