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Classification of Complaints

Classification of Complaints

A classification method should be used identify the quality, safety and performance issues that pose a high risk to individual health and to public health, and therefore require the most immediate action to protect public health and safety. Complaints may include administrative/contractual complaints and technical complaints. As soon as it has been received a complaint should be classified by the manufacturer as part of the risk management file for the product. The degree of risk will determine the timeline for action, and who should be informed. The requirement for root cause analysis will remain, irrespective of the classification.

The risk associated with use of an IVD depends, among other factors, on the intended use setting. In high-resource settings, clinical testing typically takes place in accredited laboratories by certified and proficient users using products that have undergone established pre-market assessment for their appropriateness to be used in that intended setting. However, in many countries, HIV and malaria testing for diagnosis using rapid diagnostic tests is not performed in a traditional laboratory setting and is performed by unsupported users with minimal training. In addition, the risk that an incorrect test result will lead to serious consequences (death or serious deterioration in health) for an individual or the population is greater in settings with higher disease prevalence and lower access to diagnosis, care and treatment services.

The manufacturer of a prequalified IVD is obliged to have undertaken risk management and risk assessment with respect to the IVD before placing it on the market, implementing the most stringent controls
to those aspects of design, and manufacturing and control steps where the risk is greatest. When a complaint is received, the manufacturer should review and update the risk management file for the IVD accordingly. Manufacturers, regulators and procurers will use the information generated by complaints and any other information and experience with a given IVD to determine the scope and stringency of
post-market actions in the future. On the positive side, continued acceptable results in pre-distribution lot verification testing may lead to a change from systematic sampling of each lot towards random sampling of lots.

In general, most technical complaints will be considered as an adverse event and should be classified. However, not every complaint may need to be considered as an adverse event, and not every adverse event or potential adverse event may lead to a field safety corrective action.
Classification Definition Examples
Serious adverse event (to be notified to WHO within 10 days)
  • Death of patient, user or other person.
  • Serious injury of patient, user or other person.
  • Death or serious injury of patient, user or other person did not occur but might have.
  • Any false negative result.
  • One or more individuals receive HIV-contaminated blood product that has been produced from one blood donation that was screened as HIV negative by an HIV-1/2 RDT.
  • An individual presenting for ART initiation has testing repeated to confirm their HIV diagnosis. The re-testing results are negative.
Moderate adverse event
(to be notified to WHO within 30 days)
  • Any false positive result (that resulted in misdiagnosis).
  • Higher than expected rate of anomalies leading to invalid, unreturnable or inconclusive results.
  • Invalid rate exceeds 5%.
  • High background for rapid diagnostic tests.
  • Greater than expected discrepant rate between assay 1 and assay 2 within a testing algorithm.
Mild adverse event (to be notified to WHO within 30 days)
  • Deficiency found by the user before use.
  • Adverse event caused by patient conditions.
  • Adverse event caused by expiry of IVD's service life or shelf life.
  • Malfunction protection operated correctly.
  • Negligible likelihood of occurrence of death or serious injury.
  • Unexpected and foreseeable side effects.
  • Adverse events that might be described by the manufacturer in field safety notice.
  • Control line does not appear.
  • Higher than usual background, may or may not obscure reading window and prevent reading.
  • Desiccant has changed colour.
  • A component labelled lyophilized is found to be fluid, this is discovered by the user before use.
  • Obvious damage to the packaging of a device labelled with the caution "do not use if the packaging is opened or damaged" was observed and the device was not used.