Mobidiag Novodiag NVD-BCS-A NVD-TSCA-A, User Manual

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Novodiag® System User Manual (NVD-SYST-UM) V4-0 – April 2020
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9.4. Reporting product anomalies
Mobidiag encourages users to report any anomalies observed in the performance, appearance, labelling or
packaging of products. Mobidiag will carry out a thorough analysis of possible defects, and encourages users to
report the anomalies in sufficient detail, e.g. product type, lot or serial number, along with a description of the
relevant observations and supported with photographic or other descriptive material if available. It is advisable
that products with suspected defects be quarantined and processed according to the advice of Mobidiag
representatives. Please preserve the whole product, together with the packaging material, for further analysis.
9.5. Vigilance information
In the unlikely case of a suspected hazardous situation being caused or affected by the use of Mobidiag products,
please contact Mobidiag representatives directly and without delay. See contact information in the Important
Information section. Additionally, local competent authorities have standard reporting forms available for
reporting possible adverse effects of IVD products, and users should follow any local regulations or guidance
provided by the local authorities.
10. Troubleshooting
10.1. Novodiag® Test Cartridge troubleshooting
Table 8. Actions required for Novodiag® Test Cartridge troubleshooting
Before the run
Status Action required
Blister damaged during transport Discard cartridge and use a new one
Protective cover not fully removed or white
membrane damaged Discard cartridge and use a new one
White blocker not properly secured before run Discard cartridge and use a new one
Slide broken/damaged Discard cartridge and use a new one
Leaking cartridge Discard cartridge and use a new one
Cap not properly secured/misplaced/fallen
down or suspicion of contamination Use a spare cap provided with the kit to replace the
damaged one
After the run
White blocker absent from cartridge Eject tray. If the blocker is visible on the tray pick it if not,
contact Mobidiag representative.
Slide damaged/leaking Proceed to decontamination procedure in Chapter 8
Cartridge leaking Proceed to decontamination procedure in Chapter 8
10.2. Novodiag® Instrument troubleshooting
The Novodiag® Instrument performs a self-check at startup. Possible initialisation errors are:

Motors do not reach home position.

Overheating (too warm or too cold).

Thermocycler not heating up.

Imaging system failure.

Hybridisation heating not heating up.
All these errors during startup lead to a red light on the slot LED (see Table 4).
Table 9. Actions required for Novodiag® Instrument troubleshooting
Before the run
Status Action required
Red light on slot Restart instrument. If the instrument is in a stack, restart the whole stack. If the
problem persists, contact Mobidiag representative.
Tray jammed Make sure that the Novodiag® Software has prompted to eject cartridge or
insert the cartridge. Open the door and gently pull tray to remove the
cartridge. If the problem persists, contact Mobidiag representative.