6.3 The serial number is unknown. The batch has not been found
|Alert code (FiMVS)
|The serial number is unknown. The batch has not been found.
|Neither the batch ID nor the serial number used for the transaction exist in the system for this product number. The product code used for the transaction exists in the system.
Possible root causes of the alert:
- Batch data has not been uploaded to the EMVS system.
- The data used for the transaction (batch ID AND serial number) differs from the data printed on the pack.
- Scanner reading error or erroneously changed scanned data.
- Manual data entry error.
|Alert handling procedure
Pharmacy/ Hospital pharmacy/ Dispensary/ Wholesaler
|MAH / OBP
Check the alert message: Is this the correct batch number for this product?
a) If no: it could be a scanning error by the end user or incorrect manual data entry by the end user. If you have received a photograph of the pack, ensure that the 2D code data 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 in the FiMVS system. Often the alerting pack has been successfully verified after the alert due to a data entry error. If needed, FiMVO can also contact the end user.
NOTE! If incorrect batch data has been printed on the pack, this is a product defect or a possible suspected falsification. The responsible MAH should request the wholesaler, if necessary, to place a sales ban on the batch for the duration of the investigation and perform the investigation together with the OBP. The MAH should pay particular attention to informing pharmacies, wholesalers and Fimea in order to keep them up to date with the situation and to ensure uninterrupted treatment and patient safety. If the investigations confirm that this is a falsified medicine, the product defect process should be followed (Class 1 product defect). 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 the data for this batch has not been uploaded to the EMVS. The MAH should, if appropriate, ask the distributor to place a sales ban on the batch for the period of the investigation. If the reason for the alert is that the OBP has not uploaded the batch data to FiMVS or if the data upload has been unsuccessful, the data should be uploaded without delay, and the MAH should inform all actors in the supply chain and FiMVO of the situation, and when the data has been uploaded successfully.
If needed, FiMVO will respond to inquiries as to whether the batch data has been uploaded to the FiMVS system: (email@example.com).