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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 5187470
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.The patient was hospitalized due to high blood glucose as a result of bent cannula.The patient went into the emergency and stayed there for less than 1 day.The blood glucose level when the patient arrived at the emergency, was 1230 mg/dl and 700 mg/dl when she left the emergency.She had very large ketone levels and the health care professional identified the ketone level as life threatening.The infusion had been in use for 1 day.She was treated with iv fluids and insulin and this resolved the issue.She was hospitalized for 4 days.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 Key8530499
Report Number3003442380-2019-01196
Device Sequence Number1846772
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 Number5187470
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2018
Initial Report FDA Received Date04/19/2019
Patient Sequence Number1
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