6.2 Unknown serial number
|Alert code (FiMVS)
|Unknown serial number
|The serial number used for the transaction does not exist in the system for this product code. Product code and batch ID exist in the system but the serial number is incorrect.
Possible root causes of the alert:
- Not all serial numbers in the batch have been uploaded to EMVS.
- The data in the transaction differs from the data printed on the pack.
- Scanner configuration error (serial number contains capital and small letters which interchange).
- Scanning errors or erroneous data change after the barcode has been scanned (serial number is missing one or more characters, or extra characters have appeared after the batch ID, often the beginning of the EAN code).
- Manual data entry error.
|Alert handling procedures
Pharmacy/ Hospital pharmacy/ Dispensary/ Wholesaler
|MAH / OBP
Check the serial number in the alert message, does it match the data uploaded to EMVS?
a) If no: it could be a scanning error by the end user or incorrect manual data entry by the end user, or a genuine falsification. If you have received a photograph of the pack from the end user, ensure that the data in the 2D code on the pack is correct. Also, make sure that the 2D code data is identical to the data uploaded to EMVS. If the end user has not made contact, FiMVO (firstname.lastname@example.org) can check the audit trail of the pack in the FiMVS system, if the MAH/OBP can find in the batch data a serial number that differs only to a small extent from the erroneous serial number. Often the alerting pack has been successfully verified after the alert due to a data entry error. If needed, FiMVO can contact the user.
NOTE! If the investigations confirm that this is a genuine falsified medicine, the product defect process should be followed (Class 1 product defect). The MAH should pay particular attention to informing pharmacies, wholesalers and Fimea in order to keep them up to date of the situation and to ensure uninterrupted treatment and patient safety. The MAH is responsible for the planning and implementation of the required actions. Fimea oversees that the measures are adequate and appropriate. (https://www.fimea.fi/web/en/supervision/pharmacovigilance/product_defec…).
b) If yes: it is likely that not all serial numbers in this batch have been uploaded to the EMVS. The MAH should, if appropriate, ask the distributor to place a sales ban on the batch for the duration of the investigation. The MAH together with the OBP investigates the case and performs the required corrective actions including the informing of distribution chain actors and FiMVO of the situation.
If needed, FiMVO will respond to inquiries as to whether the batch data has been successfully uploaded to FiMVS (email@example.com).