Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | AMVB043A | — |
supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis. On 14-MAR-2025, the patient received Menveo. On 14-MAR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient) and inappropriate dose of vaccine administered (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date:17-MAR-2025 The reporter stated that Menveo 2-vial was not reconstituted with the supplied diluent, but with another sterile diluent, and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.