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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY
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INSET¿; INSET I 60/6 GREY Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported by the patient's mother that her daughter's infusion set's cannula was kinked, and which led to elevated blood glucose levels.It was treated with correction bolus and multiple daily injections.Reportedly, the patient was admitted as her blood glucose was 500 mg/dl and she had diabetic ketoacidosis.The mother reported that reported, at the hospital after her site was removed, they noticed the site was kinked.During hospitalization she received, intravenous insulin drip which resolved the issue and there was no permanent damage to the patient.She was discharged from the hospital approximately two days later.The infusion set was used for one day.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
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Brand Name
INSET¿
Common Device Name
INSET I 60/6 GREY
MDR Report Key8517510
Report Number3003442380-2019-01251
Device Sequence Number1278152
Product Code FPA
UDI-Device Identifier05705244006874
UDI-Public05705244006874
Combination Product (Y/N)N
PMA/510(K) Number
K032854
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2017
Initial Report FDA Received Date04/16/2019
Patient Sequence Number1
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