Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1B511M | OT |
administration of Ipol after Temperature excursion that reached 47.03F for 41 mins due to a failure of battery backup; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 4 years old female patient (113 cm and 27.73 kg) who who received IPV (Vero) [IPol] which were exposed to temperature excursion at 47.03 Fahrenheit for 41 mins due to a failure of battery backup. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received 0.5 ml dose of suspect IPV (VERO),Suspension for injection, lot W1B511M ,expiry date:08-Sep-2025, strength:0.5 ml, frequency: one dose, via intramuscular route in unknown administration site.for prophylactic vaccination which was exposed to temperature excursion that 47.03 Fahrenheit for 41 mins due to a failure of battery backup (poor quality product administered) (Latency:same day). Reportedly,This excursion did not occur due to a human error, There was also a previous excursion on 18-Jun-2024 that reached 52 Fahrenheit for 1 hour for IPol(opened) from a different vial and was told it was still suitable for use per the stability calculator. Patient's mother notified and advised that the dose would need to be repeated. Vaccine temperature excursion due to battery backup failure on 06-Jun-2025 in the evening hours. Temperature data thermometer notified myself at home. Came into clinic to evaluate situation and restored power to fridge and freezer units. The morning of 09-Jun-2025, called Sanofi to report excursion and to determine viability. During the call, Sanofi representative asked about previous excursions. IPOL did have a previous excursion. Representative asked if any doses had been given from the vial since the excursion and I had. The representative explained that due to IPOL being in a multidose vial and being opened, the IPOL is not viable for use and should have been disposed after previous excursion.Thoroughly investigated documentation from previous excursions and determined that the staff member that was supposed to call manufacturer only used the Sanofi Temperature Stability calculator to determine stability. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 19-Jun-2025 from Other Health Care Professional in which the case classification has upgraded to Valid ICSR with no AE in which patient details has been updated, batch no W1B511M ,expiry date:08-Sep-2025, strength:0.5 ml, route has been added, however narrative amended accordingly.