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Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Contusion (1787); Erythema (1840); Hyperglycemia (1905)
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Event Date 07/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.Potential catalog number - 21-7220-24.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.
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Event Description
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It was reported that during use of a cleo® 90 infusion set, the patient's blood glucose levels "skyrocketed".The patient "kept delivering boluses" but the blood glucose levels stayed high.The patient did not think they were receiving insulin.The patient then changed the site, and "that helped".The patient confirmed their blood glucose levels have since been lowered.It was noted that there is now redness around the area and a "hard bump".No permanent injury was reported.
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Search Alerts/Recalls
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