[Adverse unidentified transfusion reactions in five French regions: analysis, results, propositions]

Adverse transfusion effects with "unidentified diagnosis" are yearly notified on the French national database "e-FIT" in various numbers and with high interregional discrepancies. The aim of this work was to analyse them in order do reach a better understanding of these notifications.

On a total of 2499 "Fiches d'Effets Indésirables Receveurs" (FEIR) registered in 2006 in five French regions, 416 with "unidentified diagnosis" were analysed. Fifty-seven percent of them were kept classified in "unidentified diagnosis". Forty-three per cent of FEIR were reclassified, some in already proposed diagnostic categories (100 EIR), some in new proposed diagnostic categories (80 EIR) as: pathological context of the patient, pains linked to transfusion, hypotension.

The study confirms the necessity to re-examine the French notification system. It underlines the insufficiency of clinical and biological investigations, which could allow to reach accurate diagnosis. It gives prominence the necessity of taking into account the patient's pathology and targets at least two diagnoses of transfusion adverse effects which are not yet proposed on the FEIR model. This work brings an overture about evolution of the French haemovigilance database which will involve further developments.