Rapports D'incidents Dans Les États Membres De L'ue - BÜHLMANN Quantum Blue Manuel D'utilisation

APPENDIX II
REFERENCES / LITERATURREFERENZEN / REFERENCES / RIFERIMENTI / REFERENCIAS
1. Fagerhol MK: Calprotectin, a faecal marker of
organic gastrointestinal abnormality. Lancet 356,
1783-4 (2000)
2. Tibble JA et al.: A simple method for assessing
intestinal inflammation in Crohn's disease. Gut 47,
506-513 (2000).
3. Tibble JA et al.: Use of surrogate markers of
inflammation and Rome criteria to distinguish
organic from nonorganic
Gastroenterol 123, 450-460 (2002)
4. Jahnsen J, Røseth AG, Aadland E.: Measurement
of calprotectin in faeces.. Tidsskr Nor Legeforen
128, 743–5 (2008)
5. Manz M et al.: Value of fecal calprotectin in the
evaluation of patients with abdominal discomfort:
an observational study. BMC Gastroenterology 12,
5 (2012).
6. Pavlidis P. et al.: Diagnostic accuracy and clinical
application of faecal calprotectin in adult patients
presenting with
primary care. Scand J Gastroenterol. 48, 1048-54
(2013)
APPENDIX III
INCIDENT REPORTING IN EU MEMBER STATES
If any serious incident in relation to this device has occurred, please report without delay to the manufacturer and
competent authority of your Member State.
MELDUNG VON ZWISCHENFÄLLEN IN EU-MITGLIEDSSTAATEN
Falls sich ein ernsthafter Zwischenfall in Zusammenhang mit diesem Gerät ereignet hat, bitte melden Sie dies umgehend
dem Hersteller und der zuständigen Behörde Ihres Mitgliedsstaates.
RAPPORTS D'INCIDENTS DANS LES ÉTATS MEMBRES DE L'UE
En cas d'incident grave en lien avec ce dispositif, signalez-le sans délai au fabricant et à l'autorité compétente de votre
État membre.
SEGNALAZIONE DI INCIDENTI NEGLI STATI MEMBRI UE
Si prega di segnalare immediatamente al produttore e alle autorità competenti del proprio paese eventuali incidenti gravi
avvenuti in relazione all'uso di questo dispositivo.
NOTIFICACIÓN DE INCIDENTES EN LOS ESTADOS MIEMBROS DE LA UE
Si se ha producido algún incidente grave en relación con este dispositivo, informe inmediatamente al fabricante y a la
autoridad competente de su Estado miembro.
NOTIFICAÇÃO DE INCIDENTES EM ESTADOS-MEMBROS DA UE
Se algum incidente sério ocorrer associado a este dispositivo, notifique sem demora o fato ao fabricante e à autoridade
competente de seu Estado-Membro.
Release date: 2020-10-30
intestinal disease.
gastrointestinal symptoms
7. Konikoff MR and Denson LA: Role of fecal
calprotectin
inflammation
Inflamm Bowel Dis 12(6), 524-34 (2006)
8. Fagerberg UL et al.: Colorectal inflammation is well
predicted by fecal calprotectin in children with
gastrointestinal symptoms. J Pediatr Gastroenterol
Nutr 40, 450-5 (2005)
9. Li F. et al.: Fecal Calprotectin Concentrations in
Healthy Children Aged 1-18 Months. PLoS ONE
10(3) (2015)
10. Zhu Q. et al. Fecal Calprotectin in Healthy Children
Aged 1-4 Years. PLoS ONE 11 (3) (2016)
11. Peura S. et al.: Normal values for calprotectin in
stool samples of infants from the population-based
longitudinal born into life study. Scandinavian
Journal of Clinical and Laboratory Investigation
78(1-2), 120-124 (2018)
in
35/36
as a biomarker of
in inflammatory bowel
Quantum Blue® fCAL
intestinal
disease.