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Clinical and Economic Impact of Falsely Decreased Calcium Values Caused by Gadoversetamide Interference

Manish J. Gandhi1, Vamsidhar R. Narra2, Jeffrey J. Brown2, Amy Guo3, Daniel S. Grosu3, Curtis A. Parvin1 and Mitchell G. Scott1

1 Department of Pathology and Immunology, Washington University School of Medicine, 660 S Euclid Ave., Box 8118, St. Louis, MO 63110.
2 Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO.
3 Bayer HealthCare Pharmaceuticals, Wayne, NJ.


Figure 1
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  		Fig. 1 —Flowchart shows outline of research protocol to determine incidence and impact of gadoversetamide calcium interference. S Cr = serum creatinine, n = number of incidents for each event, Roche = Calcium (Roche Diagnostics), Dade = Calcium/Flex Reagent (Dade Behring [now Siemens Healthcare Diagnostics]), QNS = quantity not sufficient.

 

Figure 2
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  		Fig. 2 —Flowchart shows outline of quality assurance protocol in place since October 2003. Roche = Calcium (Roche Diagnostics), Dade = Calcium/Flex Reagent (Dade Behring [now Siemens Healthcare Diagnostics]).

 

Figure 3
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  		Fig. 3 —Chart shows distribution of frequency of observed Dade minus Roche calcium values after gadoversetamide injection in all 633 instances identified during study. Black bars represent subgroup of instances in which there was discrepancy of ≥ 0.7 mg/dL between Dade and Roche calcium values after gadoversetamide injection. Roche = Calcium (Roche Diagnostics), Dade = Calcium/Flex Reagent (Dade Behring [now Siemens Healthcare.

 

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