[78461129]
The investigation determined that lower than expected myoglobin results were obtained from biorad level 1 quality control fluid using vitros myoglobin reagent on a vitros 5600 integrated system. The assignable cause was determined to be instrument related. Reagent and sample metering condition codes were being posted by the instrument at the time the lower than expected vitros myog results were generated. Ortho technical support reviewed historical biorad qc fluid performance across the two vitros 5600 systems in the laboratory and only one vitros system showed myoglobin imprecision suggesting that the issue is most likely instrument and not reagent related. The customer performed maintenance actions of flushing the reagent and sample metering probes. Following these actions, acceptable within run precision results were obtained on the affected vitros 5600 system. In addition, acceptable biorad qc performance has maintained following maintenance actions.
Patient Sequence No: 1, Text Type: N, H10
[78461130]
The investigation determined that lower than expected myoglobin results (54, 54. 143, 51. 89, 52. 517, 53. 724 and 53. 7 ng/ml versus expected 64. 3 ng/ml) were obtained from a non-vitros biorad level 1 (lot 29851) quality control fluid processed using vitros immunodiagnostics products myoglobin reagent lot 1220 on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros myoglobin results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number 1910053 / ivd 406334.
Patient Sequence No: 1, Text Type: D, B5