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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 WW S30

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BIOMERIEUX SA ETEST® BENZYLPENICIL PG 32 WW S30 Back to Search Results
Catalog Number 412265
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from (b)(6) reported discrepant results in association with the etest® benzylpenicil pg 32 ww s30 (lot 1005602990), when compared to their reference lab results. The customer stated that the discrepant results involved patient isolates and that quality control strains had no problems. The customer reported that they are seeing a high discrepancy rate for isolates that are at the penicillin meninigitis break point (i. E. 0. 06) or higher. The customer confirmed the patient results were delayed and also erroneous results were reported to the physician. The customer stated they would not provide patient details at this time. The customer stated they are testing in house and sending to a reference lab, so erroneous results would have been amended within a few days. There is no indication or report from the hospital or treating physician to biomérieux that any discrepant result led to any adverse event related to a patient's state of health. A biomérieux internal investigation will be initiated.
 
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Brand NameETEST® BENZYLPENICIL PG 32 WW S30
Type of DeviceETEST® BENZYLPENICIL PG 32 WW S30
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 les grottes isere 383,
FR
Manufacturer Contact
debra broyles
595 anglum road
st. louis, MO 63042
3147318805
MDR Report Key7619776
MDR Text Key112445061
Report Number3002769706-2018-00080
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K981135
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 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2020
Device Catalogue Number412265
Device Lot Number1005602990
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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