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.Mfr# clarification: new registration number 3012307300 (b)(4) is now being used for mfr report number, replacing registration number 2183502 (b)(4).
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It was reported that a cleo 90 infusion set failed due to lack of adhesive around the cannula or that the adhesive was stuck together, which did not allow the patient to properly adhere the set to his body.It was noted that the failures had occurred over the past 60 days from (b)(6) 2016.The patient's blood glucose was adversely affected and reported at 355mg/dl.The patient changed the infusion set and continued using his pump to address the high blood glucose.No permanent injury was reported.See mfr: 3012307300-2016-00168, 3012307300-2016-00169, 3012307300-2016-00170, 3012307300-2016-00171, 3012307300-2016-00173, 3012307300-2016-00174, 3012307300-2016-00175, 3012307300-2016-00176, 3012307300-2016-00177, 3012307300-2016-00178, 3012307300-2016-00179, 3012307300-2016-00180, and 3012307300-2016-00181.
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