BACT/ALERT? FN PLUS 410852

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 2019-08-17 for BACT/ALERT? FN PLUS 410852 manufactured by Biomerieux Inc..

Event Text Entries

[188990342] A customer in (b)(6) notified biom? Rieux of obtaining two false negative results in association with the bact/alert? Fn plus blood culture bottles (reference 410852, lot 4052871). The customer stated both bottles were incubated for five days and flagged negative. These bottles were then sub-cultured and were positive for growth of propionibacterium acnes (p. Acnes). Although the customer did follow the five day incubation protocol, p. Acnes is a fastidious slow growing microorganism which may require a longer incubation period. The bottle instructions for use (ifu) notes this a limitation of the test if fastidious microorganisms are suspected. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the 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 Number3002769706-2019-00049
MDR Report Key8904289
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-08-17
Date of Report2019-08-17
Date Mfgr Received2019-07-21
Device Manufacturer Date2019-01-21
Date Added to Maude2019-08-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX INC.
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal Code27712
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBACT/ALERT? FN PLUS
Generic NameBACT/ALERT? FN PLUS
Product CodeMDB
Date Received2019-08-17
Catalog Number410852
Lot Number4052871
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX INC.
Manufacturer Address100 RODOLPHE STREET DURHAM NC 27712 US 27712


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-17

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