Table 6 Product failures of analysers and general consumables for infection testing (n = 20).
Product failure | All analysers1 n (%) | All general consumables1 n (%) |
|---|---|---|
Number of cases | 13 (100) | 7 (100) |
No product failure | 0 (0) | 0 (0.0) |
User error | 1 (7.7) | 1 (14.3) |
Root cause not identified | 0 (0) | 0 (0) |
Product failure identified | 12 (92.3) | 6 (85.7) |
   Material defect | 0 | 1 |
   Software error | 11 | 1 |
   Calibration error | 0 | 0 |
   Electrical error | 0 | 0 |
   Mechanical error | 0 | 0 |
   Miss of specification | 0 | 1 |
   Manufacturing error | 0 | 1 |
   Incorrect instructions for use | 0 | 0 |
   Non-microbial contamination | 0 | 0 |
   Packaging error | 0 | 0 |
   Microbial contamination | 0 | 1 |
   Interference by other substances | 0 | 0 |
   Constructional fault | 1 | 0 |
   Labelling error | 0 | 1 |