ETEST? BENZYLPENICIL PG 32 WW S30 412265

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-06-20 for ETEST? BENZYLPENICIL PG 32 WW S30 412265 manufactured by Biomerieux Sa.

Event Text Entries

[112445559] A customer from (b)(6) reported discrepant results in association with the etest? Benzylpenicil pg 32 ww s30 (lot 1005703390), 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 biom? Rieux that any discrepant result led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2018-00081
MDR Report Key7619757
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-06-20
Date of Report2019-01-08
Date Mfgr Received2018-12-14
Device Manufacturer Date2017-05-17
Date Added to Maude2018-06-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318805
Manufacturer G1BIOMERIEUX SA
Manufacturer Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME LES GROTTES ISERE 383,
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETEST? BENZYLPENICIL PG 32 WW S30
Generic NameETEST? BENZYLPENICIL PG 32 WW S30
Product CodeJWY
Date Received2018-06-20
Catalog Number412265
Lot Number1005703390
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383, FR


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-20

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