Involved lot numbers reported by customer: 76x072, 75x079, and 76x114.Possible expiration date: 04/28/2021, 04/28/2020, 07/28/2016.Possible device manufacturer's date: 05/05/2016, 04/20/2015, 07/20/2016.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).
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It was reported that a cleo® 90 infusion set cannula fell off or failed to stick properly.It was noted that the infusion set fell off immediately or after an hour.The cannula may have slid over while the tape was in place.The patient's blood glucose was known to rise.The blood glucose was brought down by replacing the infusion set and administering a manual shot.No permanent injury was reported.See mfr: 3012307300-2016-00409, 3012307300-2016-00410, 3012307300-2016-00412, 3012307300-2016-00413, 3012307300-2016-00414, 3012307300-2016-00415, 3012307300-2016-00416, 3012307300-2016-00417, 3012307300-2016-00418, 3012307300-2016-00419, 3012307300-2016-00420, 3012307300-2016-00421, 3012307300-2016-00422, 3012307300-2016-00423, 3012307300-2016-00424, 3012307300-2016-00425, 3012307300-2016-00426, 3012307300-2016-00427, 3012307300-2016-00428, 3012307300-2016-00429, 3012307300-2016-00430, and 3012307300-2016-00431.
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