[91454389]
The investigation determined that a non-reproducible, lower than expected vitros glucose (glu) result was obtained from a patient sample while using vitros glu slides lot 0031-0928-7830 when tested on a vitros 5600 integrated system. The likely cause of the lower than expected vitros glu results is an issue related to the vitros 5600 system. Multiple assays results were affected indicating the issue is related to the analyzer performance and not the performance of vitros glu lot 0031-0928-7830. Only the vitros glu result breached ortho's reporting criteria. Diagnostic within run precision testing was not performed prior to service actions. However, at the time of this report, micro slide metering condition codes persist indicating service actions performed have not resolved the issue. Further service is needed to return the vitros 5600 system to the expected performance. In addition, an investigation has been initiated to determine why assay results were not suppressed at the time of the metering condition codes. The investigation is ongoing. The most likely assignable cause of this event was concluded to be an instrument issue.
Patient Sequence No: 1, Text Type: N, H10
[91454390]
A customer observed a non-reproducible, lower than expected vitros glucose (glu) result obtained from a patient sample while using vitros glu slides lot 0031-0928-7830 when tested on a vitros 5600 integrated system. Patient 2 sample vitros glu result of <1. 11 mmol/l versus the expected glu result 10. 59 mmol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. The non-reproducible, lower than expected, vitros glu result was not reported outside of the laboratory and there was no allegation of actual patient harm as a result of this event. However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5