Warning Letter: Failure to adequately review and evaluate complaints on a spreadsheet (ucm540783)

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Ofni Systems

Review of a spreadsheet of all the complaints [redacted] received from January 2016 through April 2016 revealed that eighty-six (86) out of 233 separate complaint entries were for issue codes that your firm does not routinely review and evaluate.  Of these eighty-six (86) complaint entries there were eight (8) entries that describe “high” blood glucose readings.  You have stated that unexpected “high” glucose readings are a concern because if the reading is false the patient may administer insulin when it is not needed, which could lead to possible overdose and potential organ failure.

View the original warning letter.


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