Knowledge Gaps

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  The data to support patient harm from errant BGM are inadequate due to lack of reporting and difficulty in accurately attributing responsibility for adverse events to the strip manufacturer, pharmaceutical company, patient error, or disease progression.
  
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  Reporting of adverse events through the MDR mechanism is erratic and not standardized.
  
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  Information regarding postapproval quality of BGM strips is lacking, particularly data from manufacturers of mail order strips and devices.