PREVI? COLOR GRAM 414292

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 2018-11-29 for PREVI? COLOR GRAM 414292 manufactured by Biomerieux, Sa.

Event Text Entries

[129324892] A customer in (b)(6) reported gram staining issues for blood culture samples from two patients (p1, p2), in association with the previ? Color gram instrument. The customer stated that blood culture bottles for each patient, were processed with the bact/alert? Instrument and flagged as positive. The cultures were then placed on isolation media and also gram stained. The initial gram stain results were gram negative coccobacilli (p1) and bacilli (p2). After 24 hours there was no growth on the isolation media, so the same bottles had the gram stain repeated, and the results were gram positive coccobacilli (p1) and bacilli (p2). Vitek? Ms identified both samples as listeria monocytogenes (gram positive bacilli). The customer reported that when coloring these blood culture samples in the instrument, they were accompanied by other samples in which bacterial morphology was observed adequate for each type of sample and where both gram-positive and gram-negative bacteria are detected. The customer stated the wrong result was reported to the physician but patient treatment was not impacted. The patient's clinical signs did not coincide with the symptoms of a gram-negative microorganism, so the doctor decided to continue with the initial treatment until the final result of the culture. P1 was a (b)(6) female renal patient, and p2 was a newborn patient. There is no indication or report from the hospital or treating physician to biom? Rieux 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 Number3002769706-2018-00249
MDR Report Key8116180
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-11-29
Date of Report2019-02-13
Date Mfgr Received2019-01-15
Date Added to Maude2018-11-29
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. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME, LES GROTTES ISERE 38390
Manufacturer CountryFR
Manufacturer Postal Code38390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREVI? COLOR GRAM
Generic NamePREVI? COLOR GRAM
Product CodeKPA
Date Received2018-11-29
Model Number414292
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 38390 FR 38390


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.