Serious Adverse Events Following Falsely Elevated Blood Glucose Measurements Resulting From Administ

1
Serious Adverse Events Following Falsely Elevated
Blood Glucose Measurements Resulting From
Administration of an IGIV Product Containing
Maltose

• - The CDRH Perspective
  
• 
  Patricia Bernhardt, MT (ASCP)
• 
  Office of In Vitro Diagnostic
  Device Evaluation and Safety
• 
  Center for Devices and Radiological Health

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Which Sugars Have Been Evaluated ?

• Maltose - interference demonstrated at blood
  concentrations gt13 mg/dL
• Galactose interference at gt10 mg/dL
• Xylose interference at gt9 mg/dL (the blood
  xylose concentration during a xylose absorption
  test is approx. 30 mg/dL)
• Sorbitol no interference up to 70 mg/dL
• Lactose no interference up to 5 mg/dL (10x
  normal concentration of 0.5 mg/dL)

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What is CDRH Doing ?

• Posting a reminder on the OIVD website and on
  the FDA Diabetes webpage
• Developing an upcoming Patient Safety News item
• Requesting labeling modifications of GDH-PQQ test
  strips to include potential maltose, galactose
  and xylose interference

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Example of a Warning from a GDH-PQQ Test Strip
Label

• Patients receiving peritoneal dialysis solutions
  containing Icodextrin should not use the XXX Test
  Strips.
• The injection or infusion of solutions containing
  galactose or maltose (present in some human
  immunoglobulin preparations) may cause
  overestimation of blood glucose results. Blood
  concentrations of galactose gt10 mg/dL or maltose
  gt13 mg/dL will cause overestimation of blood
  glucose results.
• Do not use during a xylose absorption test.

5
CLSI Document AST4-A2 - Glucose Monitoring in
Settings Without Laboratory Support

• - provides guidelines for performance of
  point-of-care glucose monitoring systems that
  stress quality control, training and
  administrative responsibilities
• Appendix C - Common Problems with the Use of
  
  Glucose Meters
• - lists maltose interference as a cause of
  falsely elevated results with some glucose
  dehydrogenase systems