A not reportable initial mdr assessment was determined on 8/5/2015 for the complaint received on 7/15/2015.The complaint sample (omnipod) was returned to insulet complaint department on 07/28/2015.Upon completion of the device investigation, it was found evidence of an internal leak.Its root cause was determined to be a "damaged cannula" ((b)(6) 2015).As a result of identifying this failure mode with the original complaint, it is now a reportable adverse event.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod user guide warns, "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results that fall above 250 mg/dl, follow the treatment advice of your healthcare provider.".
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