Alert Management

Unknown Batch Number

Display in the medAspis system

FMD Speed Scanner:

Control Panel:

Failed to find Batch Number

Unknown Batch Number

The alert message may indicate an attempt at counterfeiting and is automatically forwarded to the competent authorities.

Description and cause:

The scanned/entered batch number could not be found. This alert code means that the batch number and serial number passed to the system for this product code do not exist in the system. This may be due to the following reasons:

  • The batch number was not uploaded by the pharmaceutical manufacturer.
  • The batch number was transferred incorrectly due to a technical error (e.g. incorrect scanner configuration or incorrect entry in manual mode).
  • The pack is counterfeit.

Handling instructions:

The pack must be isolated and must not be dispensed until the cause of the alert has been determined.
Please compare the scanned data (visible on the display of the Speed Scanner or in the Control Panel) with the plain writing information on the pack. If these do not match, there is most likely a technical problem (scanner setting). In this case, please contact medAspis Support immediately to check the scanner configuration or the software.

The pack must be separated and the regulations of your NMVO must be adhered to.
The medAspis Alert Team is at your side as part of the Alert Guard programme.

Working Instructions

The following procedural steps must be carried out when the error message appears.

Scanning staff

If this error message occurs during testing, take the following measures:

Cross-check:

  1. Compare the scanned data on the display with the print in human readable text. If the data does not match, scan again with VERIFY.
    NOTE: If the print is also not readable, separate the pack and inform the responsible person in your company immediately.
  2. Check the pack with another scanner in VERIFY.

Actions:

  1. separate the pack
  2. check in random samples whether other packs in the delivery or in the storage compartment are also affected. Be sure to use the verification function for this check.
  3. Immediately inform your manager or the responsible person.

Responsible Person

If this error message occurs during checking, take the following measures:

Cross-check:

  1. check the pack again with VERIFY.
  2. take random samples of other packs from the same delivery or the same storage place.

Actions:

  1. The package shall be treated as if it were a counterfeit.
  2. The pack must remain in quarantine until final clarification.
  3. Take a photo of the pack for documentation or reference purposes. The 2D matrix code and the data in plain writing must be visible. Note the alert number (e.g. AlertID BE-fcc11f21-4eb2-4a6c-8adf-c33a109a5948).
  4. Inform your NMVO, the MAH and the competent authorities. Follow your NMVO’s rules for handling suspected cases (separate document).