Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until end 2007

Table 6 Product failures of consumables for analyzers for diagnostics of infective diseases since begin 1999 until end of 2007.

Product failure	Product based on cultural or biochemical methods¹	Product based on immunological methods²	Product based on molecular biological methods³	Total number of products
	n (%)	n (%)	n (%)	n (%)
Number of cases	8 (100.0)	6 (100.0)	4 (100.0)	18 (100.0)
No product failure	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
User error	2 (25.0)	0 (0.0)	0 (0.0)	2 (11.1)
Root cause not identified	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Product failure identified	6 (75.0)	6 (100.0)	4 (100.0)	16 (88.9)
Material defect	0	0	1	1
Software error	1	1	0	2
Calibration error	0	0	0	0
Electrical error	0	0	0	0
Mechanical error	0	0	0	0
Miss of specification	0	0	1	1
Production error	2	5	1	8
Incorrect instructions for use	0	0	0	0
Non-microbial contamination	0	0	0	0
Packaging error	0	0	1	1
Microbial contamination	1	0	0	1
Interference by other substances	0	0	0	0
Constructional fault	0	0	0	0
Labeling error	2	0	0	2

¹e.g., culture, strain differentiation, susceptibility testing; ²e.g., immunological typing of strains, serology, ELISA, Western blot; ³e.g., PCR, hybridisation assay

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